Senior Clinical Programmer
Employment Type: Full Time
Reference Number: 2167325
Job Description Summary
The Sr. Clinical Programmer is responsible for programming and providing complex data listings and reports in SAS to support data review activities across multiple clinical studies. This individual will collaborate with cross-functional study team members and vendors for development of data review listings and patient profiles. These activities help to ensure high quality data is achieved in support of analysis for regulatory submissions, safety monitoring and publications.
- Perform SAS programming of complex listings/reports to support Data Management data review.
- Program data listings checks as necessary to facilitate Data Management's data cleaning and reconciliation activities.
- Design and develop SAS macros, applications, and other utilities to expedite SAS programming activities and usage by Data Management, Clinical Operations, and Medical for data review, as appropriate.
- Write SAS tools and develop generic SAS programs for clinical studies, as appropriate.
- Develop programs for ad hoc reports for data review.
- Develop and maintain the programs including testing and organizing the SAS datasets, SAS programs and related documentation.
- Proactively identifies potential study issues/risks and recommends/implements solutions.
- Provide programming support to Statisticians and Statistical Programmers as needed.
- May be involved in other data management related activities including but not limited to management of documents (data management plan, CRF completion guideline, database specifications), and performs User Acceptance Testing.
What is Required
- Strong SAS programming skills required, with proficiency in SAS/Base, SAS Macros, SAS/Graph, SAS SQL.
- 5+ years of experience in programming with clinical trial data and preparing programming and validation documentation in the CRO and/or other data management activities in the pharmaceutical or biotechnology industry.
- Extensive experience of handling external data, such as lab data, PK, ECG, Imaging, etc.
- Knowledge of industry standards (CDISC, SDTM), 21 CFR Part 11, ICH guidelines and FDA regulations.
- Knowledge of standard medical coding dictionaries, such as MedDRA and WHODrug.
- Strong technical skills and experience working in clinical data management systems (EDC, IxRS); experience in Medidata RAVE preferred.
- Experience working on Oncology clinical studies preferred.
- Proven ability to work both independently and in a team setting.
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.