Associate Director, Biostatistics
Employment Type: Full Time
Reference Number: 2179751
Job Description Summary
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.
- 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
About Mirati Therapeutics, Inc.
Mirati Therapeutics, Inc. is a clinical-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 KRASG12C 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 KRASG12D inhibitor, MRTX1719, an investigational PRMT5 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.
Mirati has been named a Top Workplace by the San Diego Union-Tribune. Our passionate team are deeply motivated to participate in work that is both important and unique.
Our belief is that transforming the lives of those with cancer is more than a job -- it's the chance to be part of something game-changing.
Urgency, open-mindedness, accountability and collaboration ground our work and behavior. These shared values are central to who we are, what we do and how we do it.
Our culture is one where we challenge norms, have high-risk tolerance, and celebrate an entrepreneurial and courageous attitude full of grit and determination to make a difference. We strive to create a sense of belonging and inclusion - one in which we laugh and have fun as we drive change together.
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.
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.