Director / Senior Director, Statistical Programming (Medical Affairs)
Title: Director / Senior Director, Statistical Programming (Medical Affairs)
Job Summary: The Director / Senior Director of Statistical Programming will lead and execute all Medical Affairs programming activities. This is a unique opportunity for a hands-on leader to shape and deliver programming strategy and execution in support of real-world evidence (RWE), health economics and outcomes research (HEOR), and post-marketing studies. As the sole statistical programmer on the Medical Affairs team, you will be responsible for both strategic oversight and day-to-day programming execution
Key Responsibilities
- Lead the Medical Affairs programming activities
- Oversee the development of analysis data-sets (e.g., ADaM), tables, listings, and figures (TLFs) for RWE, HEOR, and post-marketing studies.
- Ensure programming deliverables meet regulatory, publication, and internal quality standards.
- Collaborate cross-functionally across Biostatistics, Statistical Programming, and Medical Writing.
- Drive innovation in programming practices, including automation, use of R and open-source tools, and integration of real-world data sources.
- Ensure compliance with CDISC standards, ICH guidelines, and company SOPs.
Qualifications
- Masters in Statistics (Preferred)
- 6+ years of experience in statistical programming within the pharmaceutical or biotechnology industry
- Hands-on experience in designing and analyzing clinical trial data, with proficiency in SDTM and ADaM datasets and statistical software such as SAS and R.
- Deep understanding of CDISC standards (SDTM, ADaM), regulatory requirements, and publication practices.
- Strong project management, interpersonal and communication skills.
Location:
- 3 days a week on-site in the Greater Philadelphia Area.
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