A well-established, secure and commercially active biopharma is building out its US statistical programming team. This is a senior leadership role that will oversee the build-out of a fully in-house function.

Responsibilities

• Lead the statistical programming function for the oncology portfolio
• Build and develop the new US statistical programming team
• Define programming strategy, standards, and processes
• Oversee in-house development and validation of SDTM, ADaM datasets, and TFLs
• Support regulatory interactions, including IND, NDA/BLA submissions
• Collaborate with Biostatistics, Clinical Data Management, and Regulatory on submission readiness

Experience Required

• Bachelor's or Master's degree in a relevant discipline
• Extensive SAS programming experience within pharma or biopharma; oncology background required
• Demonstrable experience working directly for a sponsor company
• Strong knowledge of CDISC standards (SDTM, ADaM) and FDA/EMA submission requirements
• Proven leadership of a programming team or function
• East Coast based only

Compensation DOE - $250,000 - $300,000 base salary + benefits