Senior Director, Statistical Programming

Role Summary

• Support the statistical programming function by implementing programming processes, standards, and SOPs for clinical trials
• Contribute to the development and maintenance of SAS programming infrastructure, processes, and data standards
• Lead programming activities for assigned projects and studies (e.g. leading submission), ensuring timely and high-quality deliverables
• Manage and oversee CROs and external vendors to ensure quality and compliance with expectations
• Collaborate closely with Biostatistics, Data Management, Clinical Operations, Regulatory, Pharmacovigilance, and other functions
• Develop and implement data review, reporting tools, and statistical applications in partnership with cross-functional teams
• Review and validate SAS programs (SDTM, ADaM, and TFLs) generated internally or by CROs
• Review SAPs, DMPs, CRFs, annotated CRFs, TFL specifications, and other study documents, providing expert programming input
• Mentor and develop programmers, fostering a high-performing and collaborative team environment
• Provide hands-on support for complex analyses and ad hoc requests as needed
• Drive process improvements and efficiencies, including the adoption of automation and AI-based solutions in programming workflows

Ideal Candidate

• Master’s Degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field
• A minimum of 12–15 years of progressive clinical trial programming experience in the biotech/pharma industry, including leadership experience
• Advanced SAS programming skills: experience with R or other statistical programming languages preferred
• Strong experience and in-depth knowledge of CDISC standards (SDTM, ADaM) and controlled terminology
• Experience supporting regulatory submissions (e.g., NDA/BLA/MAA)
• Knowledgeable in AI use in drug development and ambitious in leveraging AI to build infrastructure/workflows to expedite submission process