Remote Senior Manager, Statistical Programming

Fortvita Biologics; Palo Alto (CA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Fortvita Biologics is seeking a Sr. Manager/Associate Director of Statistical Programming to lead hands-on programming activities across Phase I–III.

This role delivers analysis datasets, tables, figures, and listings, while guiding CRO/vendor programming and ensuring submission-ready outputs for a global portfolio. The ideal candidate has 5+ years at Senior Manager level or 7+ years at AD level in statistical programming, with expert SAS and CDISC SDTM/ADaM skills.

Qualifications

• Expert knowledge of SAS, CDISC (SDTM/ADaM), and regulatory submissions.
• Experience supporting Phase I–III global clinical trials.
• Strong leadership and cross-functional collaboration across Biostatistics, Data Management, Clinical and Regulatory.

Responsibilities

• Lead statistical programming activities across development programs.
• Oversee SDTM/ADaM, Tables, Listings, and Figures (TLFs) and interim analyses.
• Support regulatory submissions (IND, NDA, BLA, MAA) and audit readiness.
• Develop and maintain scalable programming infrastructure and reusable code libraries.
• Ensure GXP compliance with ICH-GCP, 21 CFR Part 11, and global regulations.
• Partner with cross-functional teams to drive quality and efficiency.
• Drive KPI tracking, governance, and continuous improvement.

Skills

SAS

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Job description

Fortvita Biologics is seeking a Sr. Manager/Associate Director of Statistical Programming to lead hands-on programming activities across Phase I–III.

This role delivers analysis datasets, tables, figures, and listings, while guiding CRO/vendor programming and ensuring submission-ready outputs for a global portfolio. The ideal candidate has 5+ years at Senior Manager level or 7+ years at AD level in statistical programming, with expert SAS and CDISC SDTM/ADaM skills.