1712942

Job Description Summary

As Sr. Manager of Statistical Programming, you will manage programming activities to ensure they are appropriately planned and executed for all assigned clinical studies. This role will interact with Biostatistics, Clinical Data Management, Medicals, Clinical Operations and Regulatory to design, write, validate and document SAS programs in accordance with company, industry, and regulatory requirements; you will play key role in developing, implementing and evaluating statistical programming standards and processes; serve as expert on CDISC data standard; develops global macros to improve efficiency and capacity of statistical programming function. The position will provide you opportunities to demonstrate your skills, influences, make your contributions as well as for leadership growth.

Your Responsibilities

Manage and lead all programming activities in a drug development program; lead the development of timelines and resource plan

  • Anticipates resource needs and works with management to ensure adequate long-term resource allocation within a drug development program
  • Participates in the development of overall objectives and influences long-term goals of the organizations
  • Provides technical and project management leadership in SAS programs and applications designed to analyze and report complex oncology trial
  • Work with biometric team to develop submission strategy and lead programming team to create submission package.
  • Act as principal programmer leading/performing hands-on programming activities to support clinical development, CSR, submissions, publications and presentations
  • Create/review programming plan, specifications for datasets and TLFs. Expert level of understanding of CDISC standards, including SDTM and ADaM models and experienced in implementing these models.
  • Develop and validate SAS programs to produce high quality deliverables for in-house and outsourced projects in compliance with company and regulatory requirements. The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures.
  • Manage CRO programming activities; review and validate deliverables produced by CROs, independently provide solutions to issues raised by CROs
  • Familiarization with ICH guidelines, advanced knowledge of submission requirements and standards, ensure that statistical programming deliverables are in compliance with regulatory requirements, industry and company standards.
  • Having expert level of SAS programming expertise, develop global macro tools that can improve overall efficiency and capacity of programming function
  • Lead the development, implementation and continuous improvement of programming process and standard
  • May lead and supervise programming staffs
  • Effectively communicate in a project team environment, within department, among functional groups and external collaborators

What is Required

  • Minimum of BS required in Statistics, Computer Science, Life Sciences or other related fields
  • BS with 8+ years or MS with 6+ years of SAS programming experience in drug development in CRO or pharma/biotech company; experience with R language is a plus
  • Strong written and verbal communication skills
  • Oncology and submission experience preferred

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.

Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it’s the chance to be part of something bigger.

We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.

Mirati cultivates an environment where:

  • An entrepreneurial attitude is encouraged
  • Our people are empowered to speak up, embrace the gray and achieve solutions
  • Diverse experiences are an important of part making the best decisions
  • We laugh and have fun as a work family

No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati’s success.

Learn more at Mirati.com/careers.

Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.

1731872

Job Description Summary

The Manager, Medical Coding (Data Management) is responsible for performing medical coding, creating internal coding guidelines and processes, and managing medical dictionaries. This individual will work with the Medical Directors, Clinical Development Scientists, and Pharmacovigilance to ensure accurate and consistent coding for clinical data deliverables. These activities help to ensure high quality data is achieved in support of analysis for regulatory submissions, safety monitoring and publications.

Your Responsibilities

  • Performs accurate and consistent medical coding of clinical trial data per MedDRA and WHODrug, and issues queries in EDC as needed
  • Manages coding deliverables across clinical studies/programs and ensures coding reviews are completed with respect to overall study timelines
  • Develops and implements internal coding conventions, SOPs, guidelines, and processes; ensures adherence to industry standards
  • Defines and develops coding review listings in collaboration with Clinical Programming Leads
  • Works with the System Administrator to set up and maintain the coding tool/application, and participates in user acceptance testing
  • Manages the up-versioning of coded terms, as applicable
  • For outsourced studies, performs quality oversight of external vendors who are performing coding, and reviews their documentation and processes
  • Participates in the development and implementation of process improvements to support the collection, integration, monitoring, review, and reporting of data
  • Manages coding dictionary versions and subscriptions
  • Proactively identifies potential study issues/risks and recommends/implements solutions

What is Required

  • Bachelor’s degree (at a minimum) in a life science or health related field preferred
  • 6+ years of Medical Coding experience in the CRO, pharmaceutical or biotechnology industry
  • Expertise with MedDRA and WHODrug
  • Experience coding in Medidata Rave Coder preferred
  • Experience with EDC systems is required
  • Experience coding in oncology Phase I, II, and III studies preferred
  • Knowledge of industry standards, ICH guidelines, and regulatory requirements
  • Proven ability to work both independently and in a team setting

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.

Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it’s the chance to be part of something bigger.

We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.

Mirati cultivates an environment where:

  • An entrepreneurial attitude is encouraged
  • Our people are empowered to speak up, embrace the gray and achieve solutions
  • Diverse experiences are an important of part making the best decisions
  • We laugh and have fun as a work family

No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati’s success.

Learn more at Mirati.com/careers.

Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.

1708226

Job Description Summary

The Director of Biostatistics is responsible for providing technical leadership through the use of novel innovative designs; a key contributor to the clinical development plans; may lead a team of biostatisticians; evaluate, analyze, and interpret the clinical study results and ensure statistical integrity; experienced in regulatory submissions to the FDA and other regulatory agencies.

Your Responsibilities

  • Demonstrates effective contributor in working with other functional team members in the clinical development plan
  • Leads Biostatistics function at cross-functional meetings; collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
  • Validate the results of key statistical deliverables, including topline TFL, perform ad hoc and exploratory statistical analyses
  • Conduct independent statistical modeling and simulation or in collaboration with other team members to assist drug development strategy
  • Experienced in leading submission related activities; represents department in meetings at regulatory agencies
  • Support publications effort including manuscripts, conference presentations and posters
  • Proven track record to independently lead a team of biostatisticians in the evaluation and implementation of novel clinical trial designs
  • Experience in leading vendor (CRO) selection; oversight of vendors to ensure timeliness and quality of analysis and statistical outputs
  • Leads department processes and standards and trains junior department personnel as necessary to achieve department objectives

What is Required

  • A PhD in statistics, biostatistics or related field with minimum of 8 years clinical trial experience in the pharmaceutical or Biotech Companies, or MS degree with minimum of 10 years of experience; oncology experience preferred
  • Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including survival analysis, Bayesian method, missing data imputation, multiplicity adjustment
  • Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concept into layman’s term
  • Demonstrated leadership skills
  • Proficiency with statistical programming in SAS and/or R, and other statistical software such as EAST
  • Knowledgeable in CDISC standard including SDTM, ADaM
  • Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
  • BLA/NDA experience including eCTD submission

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.

Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it’s the chance to be part of something bigger.

We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.

Mirati cultivates an environment where:

  • An entrepreneurial attitude is encouraged
  • Our people are empowered to speak up, embrace the gray and achieve solutions
  • Diverse experiences are an important of part making the best decisions
  • We laugh and have fun as a work family

No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati’s success.

Learn more at Mirati.com/careers.

Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.

1708244

Job Description Summary

The Senior Manager of Biostatistician is responsible for leading one or more clinical studies, provide scientifically sound statistical support to clinical development projects including but not limited to study design, author/review statistics section in the protocol, sample size determination; author/review statistical analysis plan and mock TFL, review study randomization files, ADaM specs, CRF design, DMC charter, analyze and interpret the clinical study results, and ensure statistical integrity; provide statistical support for NDA submission related activities.

Your Responsibilities

  • Represents Biostatistics function at cross-functional meetings; collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting
  • Validate the results of key statistical deliverables, including topline TFL, perform ad hoc and exploratory statistical analyses
  • Oversight statistical vendors to ensure timeliness and quality of analysis data and statistical outputs
  • Reviews regulatory documents such as CSRs, as well as summary documents
  • Provides statistical support to other disciplines related to clinical statistics
  • Support publications, including manuscripts, conference presentations and posters.
  • Keep abreast of latest developments in statistics and drug development
  • Performs other duties as required

What is Required

  • A PhD in statistics, biostatistics or related field with minimum of 5 years clinical trial experience in pharmaceutical or Biotech Company, or MS degree with minimum 7 years’ experience; oncology experience is preferred.
  • Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including survival analysis, Bayesian method, missing data imputation, multiplicity adjustment.
  • Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concept into layman’s term. Demonstrated leadership skills.
  • Proficiency with statistical programming in SAS and/or R.
  • Knowledge of CDISC standard including SDTM, ADaM,
  • Knowledge of ICH guideline, FDA / EMA / other regulatory authority guidance

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.

Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it’s the chance to be part of something bigger.

We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.

Mirati cultivates an environment where:

  • An entrepreneurial attitude is encouraged
  • Our people are empowered to speak up, embrace the gray and achieve solutions
  • Diverse experiences are an important of part making the best decisions
  • We laugh and have fun as a work family

No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati’s success.

Learn more at Mirati.com/careers.

Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.

1710163

Job Description Summary

The Director of Biostatistics (Medical Affairs, HEOR, RWE) will provide statistical expertise to support Medical Affairs, Health Economics and Outcomes Research, and Real World Evidence generation. Responsibilities includes recommendation of study design, endpoint selection, perform statistical analysis, provide input to proposed protocol concepts, contribute to publication development and reviews, and participate in working groups across clinical development through commercialization. In this role, the director ensures all aspects of the projects meet the statistical rigors and standards, regulatory requirements, and quality deliverables are met and are aligned with clinical development and commercialization goals. The director will oversee external vendors and interprets/presents the analysis results in easily understandable terms to non-statistical audience.

Your Responsibilities

  • Provide statistical expertise to Medical Affairs and HEOR to ensure appropriate statistical principles are applied and the interpretation of the results are statistically valid
  • Partner with team members from Biometrics, Clinical Development, HEOR/RWE, Medical affairs to achieve team project goals
  • Provide statistical input to study concepts and proposals from investigators (Investigator Sponsor Trials) and ensure strategic alignment with the product lifecycle
  • Participate in the publication planning and perform exploratory analysis in support of the publication plans
  • Partner with external vendors and/or independently perform statistical modeling and analysis of patient reported outcomes data using accepted statistical methodologies and/or other advanced statistical approaches in support of value demonstration to patients and other stakeholders
  • Review and provide statistical input to protocols, reports, value/reimbursement dossiers, and other ad hoc data requests
  • Partner with cross functional team to develop and implement an effective plan to leverage RWE, where applicable
  • In collaboration with team members, select vendors to assist on projects for Medical Affairs and HEOR/RWE as necessary
  • Manage vendors by providing proper oversight to ensure quality deliverables and on-time delivery
  • Provide computational and statistical advice on complex analytic issues supporting RWE projects and be able to work in an autonomous manner; participate in disease specific RWE meetings as needed

What is Required

  • Ph.D. in statistics, biostatistics, or closely related discipline; a minimum of 8 years of experience (MS with a minimum 10 years experience) working in Medical Affairs, HEOR, and/or RWE
  • Oncology experience preferred
  • Strong programming skills in SAS and/or R and other statistical analysis software
  • Experienced in statistical modeling and simulations
  • Experienced with advanced inferential statistics (including and not limited to longitudinal data analysis, missing data methods, cost-effectiveness analysis, meta-analysis, Bayesian methods), real-world data analysis methods such as propensity scores, machine learning, and related techniques
  • Prior exposure working with value/reimbursement dossiers and interactions with regulatory agencies or HTAs, a plus
  • Demonstrated leadership experiences including the ability to influence and collaborate with peers
  • Able to manage multiple, complex projects with tight timelines
  • Excellent communication and collaboration skills; able to explain complex statistical concepts in layman’s terms

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.

Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it’s the chance to be part of something bigger.

We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.

Mirati cultivates an environment where:

  • An entrepreneurial attitude is encouraged
  • Our people are empowered to speak up, embrace the gray and achieve solutions
  • Diverse experiences are an important of part making the best decisions
  • We laugh and have fun as a work family

No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati’s success.

Learn more at Mirati.com/careers.

Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.

1712928

Job Description Summary

As Principal Statistical Programmer, you will lead programming support to oncology studies in multiple stages of clinical development. This role will interact with Biostatistics, Clinical Data Management, Medicals, Clinical Operations and Regulatory to design, write, validate and document SAS programs in accordance with company, industry, and regulatory requirements; you will play a key role in developing, implementing and evaluating statistical programming standards and processes; serve as expert on CDISC data standard; develops global macros to improve efficiency and capacity of statistical programming function. The position will provide you opportunity to demonstrate your project management and project leadership skills as well as opportunity for professional growth

Your Responsibilities

  • Manage and lead all programming activities in multiple studies; lead the development of timelines and resource plan
  • Work with biometric team to develop submission strategy and lead programming team to create submission package
  • Create/review programming plan, specifications for datasets and TLFs. Expert level of understanding of CDISC standards, including SDTM and ADaM models and experienced in implementing these models
  • Develop and validate SAS programs to produce high quality deliverables for in-house and outsourced projects in compliance with company and regulatory requirements. The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures
  • Perform conformance checking of SDTM and ADaM datasets using Pinnacle 21; recommend/ implement solutions to identified issues; ensure datasets are in compliance with submission standards
  • Create/oversee the creation of proper documentation related to statistical programs, datasets, review guides and QC documentation, ensure documentations are in compliance with SOPs and/or meeting submission requirements
  • Manage CRO programming activities; review and validate deliverables produced by CROs, independently provide solutions to issues raised by CROs
  • Familiar with ICH guidelines, advanced knowledge of submission requirements and standards, ensure that statistical programming deliverables are in compliance with regulatory requirements, industry and company standards
  • Having expert level of SAS programming expertise, develop global macro tools that can improve overall efficiency and capacity of programming function
  • Participate or lead the development, implementation and continuous improvement of programming process and standard
  • Effectively communicate in a project team environment, within department, among functional groups and external collaborators
  • Perform other programming duties as assigned

What is Required

  • Minimum of BS required in Statistics, Computer Science, Life Sciences or other related fields
  • BS with 8+ years or MS with 6+ years of SAS programming experience in drug development in CRO or pharma/biotech company; experience with R language is a plus
  • Strong written and verbal communication skills
  • Oncology and submission experience preferred

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.

Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it’s the chance to be part of something bigger.

We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.

Mirati cultivates an environment where:

  • An entrepreneurial attitude is encouraged
  • Our people are empowered to speak up, embrace the gray and achieve solutions
  • Diverse experiences are an important of part making the best decisions
  • We laugh and have fun as a work family

No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati’s success.

Learn more at Mirati.com/careers.

Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.

1581318

Job Description Summary

As Principal Statistical Programmer, you will lead programming support to oncology studies in multiple stages of clinical development. This role will interact with Biostatistics, Clinical Data Management, Medicals, Clinical Operations and Regulatory to design, write, validate and document SAS programs in accordance with company, industry, and regulatory requirements; you will play a key role in developing, implementing and evaluating statistical programming standards and processes; serve as expert on CDISC data standard; develops global macros to improve efficiency and capacity of statistical programming function. The position will provide you opportunity to demonstrate your project management and project leadership skills as well as opportunity for professional growth

Your Responsibilities

  • Manage and lead all programming activities in multiple studies; lead the development of timelines and resource plan
  • Work with biometric team to develop submission strategy and lead programming team to create submission package
  • Create/review programming plan, specifications for datasets and TLFs. Expert level of understanding of CDISC standards, including SDTM and ADaM models and experienced in implementing these models
  • Develop and validate SAS programs to produce high quality deliverables for in-house and outsourced projects in compliance with company and regulatory requirements. The deliverables include SDTM and ADaM datasets, define.xml, tables, listings and figures
  • Perform conformance checking of SDTM and ADaM datasets using Pinnacle 21; recommend/ implement solutions to identified issues; ensure datasets are in compliance with submission standards
  • Create/oversee the creation of proper documentation related to statistical programs, datasets, review guides and QC documentation, ensure documentations are in compliance with SOPs and/or meeting submission requirements
  • Manage CRO programming activities; review and validate deliverables produced by CROs, independently provide solutions to issues raised by CROs
  • Familiar with ICH guidelines, advanced knowledge of submission requirements and standards, ensure that statistical programming deliverables are in compliance with regulatory requirements, industry and company standards
  • Having expert level of SAS programming expertise, develop global macro tools that can improve overall efficiency and capacity of programming function
  • Participate or lead the development, implementation and continuous improvement of programming process and standard
  • Effectively communicate in a project team environment, within department, among functional groups and external collaborators
  • Perform other programming duties as assigned

What is Required

  • Minimum of BS required in Statistics, Computer Science, Life Sciences or other related fields
  • BS with 8+ years or MS with 6+ years of SAS programming experience in drug development in CRO or pharma/biotech company; experience with R language is a plus
  • Good written and verbal communication skills
  • Oncology and submission experience preferred

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.

Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it’s the chance to be part of something bigger.

We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.

Mirati cultivates an environment where:

  • An entrepreneurial attitude is encouraged
  • Our people are empowered to speak up, embrace the gray and achieve solutions
  • Diverse experiences are an important of part making the best decisions
  • We laugh and have fun as a work family

No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati’s success.

Learn more at Mirati.com/careers.

Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.

1621540

Job Description Summary

The Associate Director of Biostatistics is responsible for leading multiple clinical studies, providing statistical support on study design and all aspects of study conduct, including but not limited to author/review statistics section in the protocol, sample size determination; author/review statistical analysis plan and mock TFL, review study randomization files, ADaM specs, CRF design, DMC charter, analyze and interpret the clinical study results, and ensure statistical integrity.

Your Responsibilities

  • Represents Biostatistics function at cross-functional meetings; collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting.
  • Validate the results of key statistical deliverables, including topline TFL, perform ad hoc and exploratory statistical analyses
  • Oversight of vendors to ensure timeliness and quality of analysis and statistical outputs
  • Conduct independent statistical modeling and simulation or in collaboration with other team members to assist drug development strategy
  • May perform submission related activities, represent department in meetings with regulatory agencies
  • Support publications effort including manuscripts, conference presentations and posters
  • Develops department processes and standards and trains junior department personnel as necessary in order to achieve department objectives

What is Required

  • A PhD in statistics, biostatistics or related field with minimum of 6 years clinical trial experience in the pharmaceutical or Biotech Companies, or MS degree with minimum of 8 years of experience;
  • Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including survival analysis, Bayesian method, missing data imputation, multiplicity adjustment
  • Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concept into layman’s terms
  • Demonstrated leadership skills
  • Proficiency with statistical programming in SAS and/or R
  • Knowledgeable in CDISC standard including SDTM, ADaM
  • Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
  • Preferably BLA/NDA experience including eCTD submission

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.

Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it’s the chance to be part of something bigger.

We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.

Mirati cultivates an environment where:

  • An entrepreneurial attitude is encouraged
  • Our people are empowered to speak up, embrace the gray and achieve solutions
  • Diverse experiences are an important of part making the best decisions
  • We laugh and have fun as a work family

No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati’s success.

Learn more at Mirati.com/careers.

Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.

1696354

Job Description Summary

The Senior Manager, Clinical Data Management is responsible for the oversight and management of clinical data management activities conducted on Mirati clinical trials from study start-up to database lock. This role will collaborate with CRO vendors and cross-functional team members for protocol review, eCRF development and standardization, database design specifications, data review and coordination of timely delivery of complete, high quality and integrous clinical trial data deliverables. The Senior Manager, Clinical Data Management at Mirati will ensure quality standards and deliverables as per Good Clinical Data Management Practices (GCDMP) and will adhere to ICH GCP guidelines. This position reports into the Associate Director, Clinical Data Management.

Your Responsibilities

  • Oversee all data management activities for assigned studies performed by CRO
  • Serve as the Mirati DM point of contact with cross-functional team members, both internal and external to ensure on-time, quality deliverables per overall study timelines
  • Oversight of CRO/vendors to ensure quality, efficiency and consistency across assigned studies
  • Implement the data quality review strategy of clinical trial data in collaboration with cross-functional team members for assigned studies
  • Represent DM function at assigned study team meetings
  • Responsible for reviewing and ensuring quality of key DM documents, DMP, data review plans, eCRF Completion Guidelines, Data transfer specifications
  • Lead User acceptance testing activities for database and edit check specifications
  • Oversee vendor data reconciliation (i.e. IXRS, central laboratory data, SAE) within the clinical database to include quality control review of queries, query responses, manual and programmed custom reports
  • Manage Mirati user administration and access to the EDC system for assigned studies
  • May serve as subject matter expert in assigned area(s)
  • Participate in the development of sponsor Data Management SOPs, work instructions, and process improvements
  • Mentor junior staff on areas associated with tasks on assigned study
  • Maintain internal data management study level documentation in audit ready status
  • Perform other duties as requested by management

What is Required

  • BS or MS, preferably in the scientific/healthcare or related field
  • 8+ years industry experience as Lead Clinical Data Management in the Pharmaceutical or Biotechnology industry
  • Experience in oncology Phase I, II, and III studies preferred
  • Ability to succeed in a fast-paced, mid company sized environment with the ability to manage a variety of projects simultaneously. Must be self-starter and function under minimal supervision
  • High attention to detail including a proven ability to manage multiple competing priorities
  • Working knowledge of GCP, FDA regulations, ICH guidelines, CDISC, CDASH, 21 CFR Part 11 and GCDMP
  • Detail oriented, with strong communication and prioritization skills, critical thinking, planning and organizational skills
  • Proficient working knowledge of EDC (Medidata Rave preferred) and IXRS/IRT solutions
  • Experience working in an outsourced clinical data management model with full service global CROs and providers

About Mirati Therapeutics

Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati’s vision is to unlock the science behind the promise of a life beyond cancer.

For more information about Mirati Therapeutics, visit us at Mirati.com or follow us on LinkedIn.

Why Join?

At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.

Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it’s the chance to be part of something bigger.

We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.

Mirati cultivates an environment where:

  • An entrepreneurial attitude is encouraged
  • Our people are empowered to speak up, embrace the gray and achieve solutions
  • Diverse experiences are an important of part making the best decisions
  • We laugh and have fun as a work family

No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati’s success.

Learn more at Mirati.com/careers.

Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.

1589397

Mirati Therapeutics (NASDAQ: MRTX) is a San Diego-based late-stage biotechnology company relentlessly focused on translating drug discovery and research into new treatments for patients by advancing and delivering novel therapeutics that target the genetic and immunologic drivers of cancer. Mirati is advancing a novel pipeline to treat large patient populations across multiple programs and tumor types, including two programs, adagrasib (MRTX849) and sitravatinib, in registration-enabling studies to treat non-small cell lung cancer (NSCLC).

Adagrasib is an investigational small molecule and selective KRAS G12C inhibitor in clinical development as a monotherapy and in combinations. MRTX1133 is an investigational small molecule, potent and selective KRAS G12D inhibitor in preclinical development.

Sitravatinib is an investigational spectrum-selective inhibitor of receptor tyrosine kinases (RTK) designed to enhance immune responses through the inhibition of immunosuppressive signaling. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including a Phase 3 trial of sitravatinib in combination with nivolumab in NSCLC.

The Company has initiated plans to prepare for the commercialization of adagrasib by establishing its commercial and medical affairs team. Mirati’s ambition is to continue to recruit and a build a world-class, high-performing team with a shared passion and dedication for transforming the future of cancer treatment.

We are Mirati

Our mission is to discover, design, and deliver breakthrough therapies to transform the lives of cancer patients and their loved ones. We have built a culture fueled by accountability, urgency, collaboration and open-mindedness, and have established ourselves as an innovator within our industry. As we grow, we are looking to build diverse teams, with skilled individuals that are passionate about their work.

Why join us?

The Associate Director of Biostatistics is responsible for leading multiple clinical studies, provide statistical support on study design and all aspects of study conduct, including but not limited to author/review statistics section in the protocol, sample size determination; author/review statistical analysis plan and mock TFL, review study randomization files, ADaM specs, CRF design, DMC charter, analyze and interpret the clinical study results, and ensure statistical integrity.

Your Responsibilities:

  • Represents Biostatistics function at cross-functional meetings; collaboratively within biometrics teams and with cross-functional teams to meet product deliverables and timelines for statistical data analysis and reporting.
  • Validate the results of key statistical deliverables, including topline TFL, perform ad hoc and exploratory statistical analyses
  • Oversight of vendors to ensure timeliness and quality of analysis and statistical outputs
  • Conduct independent statistical modeling and simulation or in collaboration with other team members to assist drug development strategy
  • May perform submission related activities, represent department in meetings with regulatory agencies
  • Support publications effort including manuscripts, conference presentations and posters
  • Develops department processes and standards and trains junior department personnel as necessary in order to achieve department objectives

What is Required:

  • A PhD in statistics, biostatistics or related field with minimum of 6 years clinical trial experience in the pharmaceutical or Biotech Companies, or MS degree with minimum of 8 years of experience;
  • Advanced knowledge of statistical methods in clinical study designs (adaptive, Bayesian), statistical analysis methods including survival analysis, Bayesian method, missing data imputation, multiplicity adjustment
  • Demonstrated written and excellent communication and interpersonal skills, with the ability to translate statistical concept into layman’s term
  • Demonstrated leadership skills
  • Proficiency with statistical programming in SAS and/or R
  • Knowledgeable in CDISC standard including SDTM, ADaM
  • Familiar with ICH guideline, FDA / EMA / other regulatory authority guidance
  • Preferably BLA/NDA experience including eCTD submission

Mirati’s policy is to provide equal employment opportunities to all applicants and employees without regards to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic informations, or any other basis protected by applicable law.

Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.

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