Associate Director, Statistical Programming
Employment Type: Full Time
Reference Number: 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
- 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.
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.