Director / Senior Director, Statistical Programming (Medical Affairs) Position Available In Philadelphia, Pennsylvania

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.