Department: Program Management
Employment Type: Full Time
Reference Number: 1732071
Job Description Summary
The 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 Biometrics, Clinical Science, Medical, and Clinical Safety and Contract Research Organizations (CROs) 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 activities.
- Design and develop SAS macros, applications, and other utilities to expedite SAS programming activities and usage by Data Management, Clinical, and Medical for data review, as appropriate.
- Write SAS tools and develop generic SAS programs for clinical studies, as appropriate.
- Develop programs for patient profiles and/or 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
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.