Sr. Programmer, Statistical Programming
Employment Type: Full Time
Reference Number: 2356204
Job Description Summary
As Sr. Programmer, Statistical Programming, you will lead programming support for multiple complex 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, and validate 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
- Lead programming support for multiple complex oncology studies, provide input to timeline development, and resource assessment
- Create/review programming plan, specifications for datasets and TLFs. Advanced knowledge with CDISC conventions, i.e., SDTM and ADaM models and experienced in implementing these models
- Develop and validate SAS® programs to produce high quality deliverables for in-house projects within set timelines in accordance 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
- Manage CRO programming activities; review and validate deliverables produced by CROs, independently provide solutions to issues raised by CROs
- Lead the creation and review of analysis file specification for ISS and ISE; program and validate ISS and ISE
- Having advanced level of programming expertise, create and validate SAS macros and utilities to automate standard and frequent tasks
- 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
- Review and provide input on documents produced by other Biometric functions such as: statistical analysis plans; TFL shells; data management plans; data transfer plans and case report forms
- Contribute to the development, implementation and continuous improvement of programming processes 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 Computer Science, Statistics, Life Sciences or other related field
- BS with 6+ years or MS with 4+ years of SAS programming experience in drug development in CRO or pharma/biotech company
- Good written and verbal communication skills
- Oncology experience preferred, and submission experience is a plus
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 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, 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.