Director, Biostatistics - Virology - Foster City, CA or Parsippany, NJ
Gilead Sciences
August 25, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Job Description
The Director, Biostatistics will be primarily responsible for the business, operational, and compliance aspects of Virology drug discovery, development, and marketed products.
Key Responsibilities
- Provide statistical leadership to Virology clinical trials: develop trial design options and provide decision support.
- Serve as statistical lead for a specific Virology molecule/indication in Health Authority interactions; maintain an accountability thread to TA head.
- Collaborate with Statistical Programming, Biostatistics, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory, and Project Management to meet data analysis and reporting deliverables and timelines.
- Apply regulatory requirements regarding statistical principles to meet regulatory, scientific, and business objectives.
- Collaborate with study investigators and internal/external experts to present and publish trial results and statistical analyses.
- Negotiate project timelines; develop long-term staffing plans; provide staff career development; participate in strategic risk assessment based on statistical analyses/principles.
- Oversee and contribute to completion of technical/operational statistical activities for multiple development programs via internal/external resources.
- Provide overall leadership for a departmental strategic initiative with experience supervising personnel.
Basic Qualifications
- PhD with 8+ years industry experience; OR Masters with 10+ years; OR Bachelors with 12+ years.
Preferred Qualifications
- Hands-on drug development experience (trial design and analysis of phase 1–3); NDA/BLA filing through label negotiation.
- Biomedical statistical analysis experience; SAS and R preferred.
- Effective communication; strong cross-functional collaboration.
- Strategic, holistic problem-solving; proactive obstacle anticipation.
- Ability to assemble/lead high-performing teams.
People Leader Accountabilities
- Create Inclusion; Develop Talent; Empower Teams.
The Director, Biostatistics will be primarily responsible for the business, operational, and compliance aspects of Virology drug discovery, development, and marketed products.
Key Responsibilities
- Provide statistical leadership to Virology clinical trials: develop trial design options and provide decision support.
- Serve as statistical lead for a specific Virology molecule/indication in Health Authority interactions; maintain an accountability thread to TA head.
- Collaborate with Statistical Programming, Biostatistics, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory, and Project Management to meet data analysis and reporting deliverables and timelines.
- Apply regulatory requirements regarding statistical principles to meet regulatory, scientific, and business objectives.
- Collaborate with study investigators and internal/external experts to present and publish trial results and statistical analyses.
- Negotiate project timelines; develop long-term staffing plans; provide staff career development; participate in strategic risk assessment based on statistical analyses/principles.
- Oversee and contribute to completion of technical/operational statistical activities for multiple development programs via internal/external resources.
- Provide overall leadership for a departmental strategic initiative with experience supervising personnel.
Basic Qualifications
- PhD with 8+ years industry experience; OR Masters with 10+ years; OR Bachelors with 12+ years.
Preferred Qualifications
- Hands-on drug development experience (trial design and analysis of phase 1–3); NDA/BLA filing through label negotiation.
- Biomedical statistical analysis experience; SAS and R preferred.
- Effective communication; strong cross-functional collaboration.
- Strategic, holistic problem-solving; proactive obstacle anticipation.
- Ability to assemble/lead high-performing teams.
People Leader Accountabilities
- Create Inclusion; Develop Talent; Empower Teams.