Dir, Statistical Programming

Fortvita Biologics is a San Francisco Bay Area–based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs. Building on our foundation in oncology, we are expanding into cardiovascular and metabolic diseases, immunology, and ophthalmology, applying our scientific rigor and platform capabilities to areas of growing global health burden. Our expertise covers antibody discovery and engineering, including monoclonal, bispecific, and polyspecific antibodies, as well as antibody-drug conjugates, all supported by development strategies rooted in thoughtful design and agile execution.

Our clinical development footprint covers the U.S., Australia, and key regions across APAC and Europe, including the EU, UK, South Korea, and Japan. With more than 100 professionals across research, development, regulatory, and operations, we bring deep expertise and a global perspective to every program. Guided by our mission to transform research breakthroughs into therapeutic excellence and driven by our vision to improve lives through scientific innovation, we are committed to delivering meaningful impact for patients around the world.

Reporting to the Vice President of Biostatistics, the Director of Statistical Programming provides strategic leadership and hands‑on oversight of statistical programming across Phase I–III clinical studies. The Director leads programming standards, infrastructure, regulatory deliverables, vendor oversight, and cross‑functional collaboration to ensure high‑quality, submission‑ready outputs supporting Fortvita's global clinical development portfolio.

• Support the Vice President, Biostatistics in executing the statistical programming strategy.
• Build and mentor a high‑performing programming team.
• Establish programming standards, governance, and best practices.
• Support departmental planning and resource forecasting.

• Oversee SDTM, ADaM, Tables, Listings, and Figures (TLFs).
• Support interim analyses, database lock, and final study reporting.
• Support integrated analyses (ISS/ISE) where applicable.

• Lead programming support for IND, NDA, BLA, and MAA submissions.
• Ensure compliance with FDA, EMA, PMDA, ICH, and CDISC requirements.

• Lead the development and maintenance of scalable programming infrastructure for the Biometrics department.
• Maintain programming environments, reusable code libraries, macros, validation frameworks, and automation tools.
• Establish version control, validation standards, and inspection‑ready documentation.
• Evaluate emerging technologies that improve programming efficiency and scalability.
• Oversee statistical programming vendors and FSP partners.
• Establish KPIs, governance, budgets, and quality expectations.

• Partner with Biostatistics, Clinical Data Management, Clinical Operations, Clinical Development, Regulatory Affairs, Medical Writing, and Quality.
• Provide programming expertise during protocol and SAP development.

• Maintain inspection readiness and support audits and regulatory inspections.
• Ensure compliance with ICH‑GCP, 21 CFR Part 11, and global regulations.

• Develop KPIs and dashboards.
• Drive continuous improvement and perform other duties as assigned

• 10+ years of statistical programming experience.
• 5+ years of leadership experience.
• Expert knowledge of SAS, CDISC (SDTM/ADaM), and regulatory submissions.
• Experience supporting Phase I–III global clinical trials.

• Experience in oncology or immunology.
• Experience in a small or mid‑sized biotechnology company.
• Experience building a statistical programming function.

• Strategic leadership with hands‑on execution.
• Strong analytical and communication skills.
• Commitment to quality and continuous improvement.

• The base salary range for this position is $ to $. Actual starting pay is determined based on the candidate's years of relevant…