Senior Director, Clinical Statistical Programming

Fortvita Biologics; Palo Alto (CA); On-site; USD 220,000 - 270,000; Full time

Job summary

Fortvita Biologics is seeking a Director of Statistical Programming to lead strategic programming for Phase I–III trials and ensure submission-ready outputs across the global portfolio. The role reports to the VP of Biostatistics and will build a high-performing team in a Bay Area setting.

The ideal candidate will oversee SDTM/ADaM, TLFs, and regulatory submissions, driving standards, governance, and automation within the Biometrics department to deliver high-quality results.

Qualifications

• 10+ years of statistical programming experience.
• 5+ years of leadership experience.
• Experience with SDTM/ADaM and regulatory submissions.
• Experience supporting Phase I–III global clinical trials.

Responsibilities

• Lead SDTM/ADaM, Tables, Listings, and Figures (TLFs).
• Oversee regulatory submissions and evidence generation.
• Develop and enforce programming standards, governance, and infrastructure.
• Mentor and grow a high-performing programming team.

Skills

Leadership

Strategic thinking

Communication

Mentoring

Tools

SAS

CDISC

Job description

Fortvita Biologics is seeking a Director of Statistical Programming to lead strategic programming for Phase I–III trials and ensure submission-ready outputs across the global portfolio. The role reports to the VP of Biostatistics and will build a high-performing team in a Bay Area setting.

The ideal candidate will oversee SDTM/ADaM, TLFs, and regulatory submissions, driving standards, governance, and automation within the Biometrics department to deliver high-quality results.