Senior Director of Statistical Programming
Oncology & Hematology Biotech
Location: South San Francisco - Onsite 2 days/week
About the Opportunity
Our oncology‑hematology biotechnology organization is seeking a highly experienced Senior Director of Statistical Programming to lead the strategic direction, execution, and delivery of statistical programming activities across our clinical development pipeline. This senior leader will champion high‑quality, CDISC‑compliant datasets and outputs that support submissions from early development through late‑phase and regulatory filings.
You will partner closely with Biostatistics, Data Management, Clinical Science, Pharmacovigilance, and DMPK to ensure data integrity, regulatory readiness, and operational excellence across all oncology and hematology programs.
Key Responsibilities
Leadership & Oversight
- Oversee all statistical programming activities across multiple programs and therapeutic areas, ensuring high‑quality, timely, and compliant deliverables.
- Provide strategic leadership to a team of statistical programmers, offering mentorship, performance management, and technical direction.
- Drive programming innovation, automation, and best practices within a fast‑paced oncology/hematology environment.
- Collaborate with senior leadership to influence programming strategy, resource planning, and long‑term infrastructure development.
Regulatory & CDISC Excellence
- Lead the design, development, validation, and documentation of SAS programs that generate CDISC‑compliant SDTM and ADaM datasets.
- Direct the creation of submission‑ready outputs, including Define.XML, reviewer guides, Pinnacle 21 validation packages, and SAS transport files.
- Oversee integrated analysis datasets and outputs (ISE/ISS) for NDA/BLA filings.
- Ensure all activities align with FDA, EMA, PMDA, ICH, and other global regulatory requirements.
Cross‑Functional Collaboration
- Serve as the primary programming partner to Biostatistics Leads, contributing to Statistical Analysis Plans (SAPs), TLF development, protocol design, CRF development, and data‑collection strategies.
- Collaborate closely with IT to maintain and enhance a secure, scalable, GxP‑compliant SAS environment.
- Provide subject‑matter expertise and guidance during audits, regulatory inspections, and internal reviews.
Process, Quality, and Innovation
- Develop, enhance, and maintain programming SOPs, Work Instructions, templates, and standards.
- Drive implementation of robust documentation practices and reproducible programming workflows.
- Lead initiatives to automate processes, streamline data flow, and improve programming efficiency.
Qualifications
- MS or higher in Statistics, Mathematics, Computer Science, or related discipline.
- 12+ years of statistical programming experience in the biopharmaceutical industry, with extensive hands‑on SAS programming.
- 10+ years of experience using CDISC standards (SDTM & ADaM) and 6+ years of experience supporting oncology trials, including deriving RECIST endpoints.
- Expertise in Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL, and SAS/ODS.
- Demonstrated leadership experience overseeing programming teams and managing multiple complex studies.
- Strong knowledge of FDA, ICH, EMA, and PMDA regulations and guidance.
- Experience implementing GxP‑compliant SAS environments in partnership with IT.
- Proven ability to develop SOPs, standards, and programming infrastructure.
- Exceptional communication skills and ability to lead in a cross‑functional, fast‑moving environment.
- Strong project management, problem‑solving, and decision‑making abilities.
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