Position Overview
As a Senior Statistical Programmer, you will leverage advanced SAS programming skills, proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I‑IV clinical trials. This role can be performed as fully remote.
Our values
- We believe in applying scientific rigor to reveal the full promise inherent in data.
- We nurture intellectual curiosity and encourage everyone to approach new challenges with enthusiasm and the desire for discovery.
- We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities.
- We prize innovation and seek intelligent solutions using leading‑edge technology.
Responsibilities
- Perform data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming.
- Generate and validate SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs).
- Production and QC/validation programming.
- Generate complex ad‑hoc reports utilizing raw data.
- Apply strong understanding/experience of efficacy analysis.
- Create and review submission documents and eCRTs.
- Communicate with and/or respond to internal cross‑functional teams and client for project specifications, status, issues or inquiries.
- Perform lead duties when called upon.
- Serve as team player, willing to go the extra distance to get results, meet deadlines, etc.
- Be adaptable and flexible when priorities change.
Qualifications
- Bachelor’s degree in one of the following fields: Statistics, Computer Science, Mathematics, etc.
- At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor’s degree or equivalent. At least 6 years of related experience with a master’s degree or above.
- Study lead experience, preferably juggling multiple projects simultaneously.
- Strong SAS data manipulation, analysis and reporting skills.
- Solid experience implementing the latest CDISC SDTM / ADaM standards.
- Proficiency in efficacy analysis.
- Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials’ data.
- Submissions experience utilizing define.xml and other submission documents.
- Experience supporting immunology, respiratory or oncology studies would be a plus.
- Excellent analytical & troubleshooting skills.
- Ability to provide quality output and deliverables, in adherence with challenging timelines.
- Ability to work effectively and successfully in a globally dispersed team environment with cross‑cultural partners.
Seniority level
Mid‑Senior level
Employment type
Full‑time
Job function
- Health Care Provider, Research, and Information Technology
Industries
- Biotechnology Research, Hospitals and Health Care, and Pharmaceutical Manufacturing