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.