Director, Statistical Programming

Job Title: Associate Director / Director / Senior Director, Statistical Programming

Location: Philadelphia (Hybrid)

Position Overview: This Statistical Programmer leader will take an active, hands-on role in shaping strategy, driving innovation, and executing complex data analyses across clinical and regulatory programs. The ideal candidate will bring a deep expertise in statistical programming, a strong grasp of regulatory standards, and fluency in modern data science methodologies.

Key Responsibilities:

• Prepare and/or review CDISC (SDTM and AdAM) data specifications to ensure regulatory acceptability.
• Create programming specifications by interpreting Statistical Analysis Plans, ensuring they can be utilized by both internal teams and external CRO partners to develop validated programming in support of R&D objectives.
• Collaborate with cross-functional teams to interpret the clinical trial data, develop efficient procedures for clinical data review, and other data-quality initiatives.

Experience:

• Master's degree in Statistics or Biostatistics (Preferred)
• Demonstrated experience in leading a clinical asset through all phases of development
• Proven expertise in regulatory submissions, including leading and managing submission processes
• Must have leadership (People/Asset/Submission) experience; participation-only experience is not suitable for this role
• SAS / R Programming Experience (R is preferred)