Director, Statistical Programming

Position Title: Director, Statistical Programming 

Department: Clinical Data Sciences & Analytics  

Reports To: Head of Statistical Programming 

Location: South San Francisco, CA or Princeton, NJ – On-site 4 days per week (Mon to Thurs)  

Job Overview: 

The Director of Statistical Programming will serve as the compound lead, responsible for programming strategy and delivery across all studies and integrated analyses for an assigned compound. This role will build and lead a team of statistical programmers and oversee internal and outsourced programming activities, ensuring quality, consistency, and timely delivery of clinical reporting and regulatory submission deliverables, while providing technical leadership and remaining hands-on in SAS/R for complex programming and technical review as needed. 

This position will serve as the primary Statistical Programming representative on compound teams, partnering with Biostatistics and Clinical Data Management (CDM) to align data collection, analysis requirements, and programming plans. The compound lead will establish consistent programming standards across studies, coordinate resources and timelines, and proactively address delivery risks. Additionally, this position will contribute to establishing SOPs and programming standards and modernizing statistical reporting with open-source tools. 

ESSENTIAL DUTIES AND RESPONSIBILITIES 

Key Project Responsibilities: 

• Serve as the compound programming lead, accountable for study- and compound-level programming deliverables in collaboration with the lead biostatistician and cross-functional teams. 

• Manage and develop statistical programmers supporting the compound, including setting objectives, providing mentoring, and conducting performance reviews. 

• Develop and maintain programming plans, coordinate timelines and resource needs across studies, and proactively address delivery risks, allocating resources within the compound team and escalating cross-program resource constraints and unresolved issues to the Head of Statistical Programming. 

• Lead programming review of SAPs, Data Presentation Plans, and Table Shells across the compound to align with development objectives and ensure clarity, consistency, and completeness of programming assumptions and requirements. 

• Lead the programming team to produce and/or validate SDTM, ADaM, and TLF deliverables across studies and integrated analyses for CSRs, regulatory requests, publication needs, and ad hoc analyses, remaining hands-on for complex programming and technical review. 

• Manage CROs and contractors supporting the compound, defining scope and acceptance criteria, monitoring outsourcing budgets, and ensuring compliance, quality of deliverables, and timelines. 

• Collaborate with biostatisticians and clinical development colleagues to develop/review TLF shells, SDTM, and ADaM specifications, establishing consistent data standards and derivation conventions across studies to support compound-level analyses. 

• Work closely with Data Management and Biostatistics teams to ensure database-lock readiness and the accuracy and traceability of final datasets, analyses, and reports across the compound. 

• Develop company tools, such as R packages, macros, and interactive data dashboards (e.g., with Shiny), to enhance the efficiency and capacity of the Statistical Programming team. 

• Oversee the development and validation of define.xml and supporting reviewer guides. Lead preparation of the compound’s programming deliverables for NDA eSubmissions, including integrated analyses, and coordinate programming support for responses to regulatory questions. 

Initiative Responsibilities: 

• Partner with the Head of Statistical Programming to lead initiatives that implement innovative strategies and technologies to enhance programming processes, driving adoption across the compound studies. 

• Contribute to establishing departmental Statistical Programming standards and SOPs, and lead implementation of programming strategies, specifications, and standardized analyses across studies within the assigned compound. 

• Proactively identify gaps and risks in programming capabilities and processes, lead improvement plans, and share lessons learned and best practices across the Statistical Programming team. 

Qualifications and Preferred Skills 

Education: 

• Master’s degree in Statistics/Biostatistics, Mathematics, Computer Science, or a related field. 

Experience and Skill Set: 

• 10+ years of statistical programming experience in the pharmaceutical, biotech, or CRO clinical trial environment, including demonstrated experience leading programming across multiple studies within a compound or development program and experience managing statistical programmers. 

• Advanced SAS and R programming skills, with experience using Git for version control required. Extensive hands-on experience with SDTM, ADaM, and TLF programming. 

• In-depth knowledge of CDISC standards (SDTM, ADaM) and regulatory submission requirements, with hands-on experience applying these standards and leading programming deliverables for at least one NDA/BLA or MAA submission. 

• Strong knowledge of the drug development process, study design, statistical methodology, regulatory guidance, statistical concepts, and medical terminology, with the ability to translate analysis plans into programming requirements. 

• Excellent communication and collaboration skills, with the ability to represent Statistical Programming on cross-functional compound teams, influence decisions, and communicate technical risks and recommendations clearly. 

• Broad expertise in statistical programming and developing compound-level programming strategies, including cross-study standards, resource planning, timeline management, and risk mitigation. 

• Practical experience with data validation, define.xml generation, and tools such as Pinnacle 21, including preparation and review of supporting reviewer guides and resolution or documentation of conformance findings. 

• Experience managing outsourced programming activities and overseeing CROs and contractors, including defining scope and quality expectations, monitoring timelines and budgets, and resolving delivery issues. 

• Demonstrated ability to provide technical leadership and mentoring to study programmers and lead a programming team while remaining hands-on in programming and technical review. 

• Prefer experience with regulatory audits and inspections (e.g., FDA, PMDA, NMPA, EMA) is a strong advantage.