Director, Statistical Programming - Head of Statistical Programming
(Hybrid 3 days per week in South San Francisco, CA)
Position Overview
The Director of Statistical Programming will provide strategic oversight, planning, and execution of the statistical programming function to support an expanding portfolio of clinical development programs. This role will collaborate with key stakeholders across Biometrics, Data Management, Biostatistics, and Data Science to build a top-tier biometrics function. The Director will ensure high-quality, timely, and accurate delivery of statistical programming outputs and will oversee both internal and external programming resources. In addition, this leader will provide scientific leadership, working cross-functionally to ensure data deliverables meet the highest standards for regulatory submission.
This position reports to the Vice President of Biometrics and will lead the statistical programming function, contributing to delivery excellence, and providing technical, strategic, and operational direction.
Key Responsibilities
- Provide strategic leadership to the statistical programming function, aligning with organizational goals and clinical program objectives.
- Lead and manage the statistical programming team, fostering a culture of collaboration, innovation, and excellence.
- Provide strategic input into the setup of clinical data repositories and ensure compliance with 21 CFR Part 11 standards for SAS computing environments.
- Collaborate with cross-functional teams (Medical, Biostatistics, Data Management, Medical Writing, Safety) to develop and implement standardized analysis datasets, Tables, Listings, and Figures (TLFs), and a global standard eCRF library for multiple therapeutic areas.
- Develop, test, validate, and execute standard macros and utilities to support statistical programming activities.
- Review clinical trial documentation such as clinical protocols, data management plans, CRFs, SAP, and CSRs.
- Act as the primary point of contact for all statistical programming activities outsourced to CROs, ensuring timely and quality deliverables.
- Lead the development and optimization of biometric processes, ensuring efficiency, quality, and compliance with industry best practices.
- Provide technical leadership and project management for multiple studies, overseeing statistical programming deliverables.
- Support programming for clinical study reports (CSR), integrated summaries of safety (ISS), efficacy (ISE), DSUR, and other regulatory submissions.
- Generate/review CDISC SDTM and ADaM datasets, SAS export files, and Define.xml for electronic submission.
- Collaborate with key internal stakeholders to define programming-related study deliverables.
- Perform additional duties as assigned.
Qualifications
- Bachelor’s or Master’s degree in Statistics, Mathematics, or a related field, with 10+ years of experience in pharmaceutical or biotech statistical programming.
- Expertise in CDISC submission requirements (SDTM, ADaM, Define.xml, validation rules).
- Advanced experience in writing CDISC standard dataset specifications and generating SDTM/ADaM datasets.
- Strong proficiency in SAS programming (SAS Base, SAS/Macro, SAS/Graph, SAS/Stat).
- Experience managing CROs and/or centralized statistical programming teams.
- Solid understanding of the drug development process, especially in a biotech setting.
- Excellent communication and collaboration skills to effectively work across multidisciplinary teams.
