Director, Biostatistics - Virology - Foster City, CA or Parsippany, NJ
Gilead Sciences
August 23, 2026
Remote friendly (Parsippany, NJ)
United States
Clinical Research and Development
Job Description
The Director, Biostatistics will primarily be responsible for business, operational, and compliance aspects of Virology drug discovery, development, and marketed products. Supports Virology drug development by collaborating on development plans, regulatory interactions, and commercial evaluation of a Virology compound in one or more indications.
Key Responsibilities
- Provide statistical leadership to Virology clinical trials: develop trial design options and provide decision support.
- Act as statistical lead for a specific Virology molecule/indication in Health Authority interactions; maintain an accountability thread to TA head.
- Collaborate with Statistical Programming, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory, and Project Management to meet deliverables and timelines for statistical analysis/reporting.
- Apply regulatory requirements to ensure meeting regulatory, scientific, and business objectives.
- Collaborate with investigators, external experts, and internal colleagues to present and publish trial results/statistical analyses.
- Negotiate timelines under constraints; support long-term staffing plans and staff development; participate in strategic risk assessment.
- Oversee and contribute to technical/operational statistical activities for multiple development programs through internal/external resource management.
- Provide leadership for a departmental strategic initiative; directly supervise personnel.
Basic Qualifications
- PhD with 8+ years industry experience, OR
- Master’s with 10+ years, OR
- Bachelor’s with 12+ years.
Preferred Qualifications
- Hands-on drug development experience (trial design/analysis for phase 1-3); participation in NDA/BLA filing through label negotiation.
- Biomedical statistical analysis experience; SAS and R preferred.
- Strong verbal/written communication; ability to convey complex concepts clearly.
- Collaboration/interpersonal skills across diverse cross-functional teams.
- Holistic problem analysis; anticipates obstacles and proactively develops solutions.
- Ability to assemble/lead high-performing teams.
People Leader Accountabilities
- Create Inclusion; Develop Talent; Empower Teams.
Application Instructions
- Please apply via the Internal Career Opportunities portal in Workday.
The Director, Biostatistics will primarily be responsible for business, operational, and compliance aspects of Virology drug discovery, development, and marketed products. Supports Virology drug development by collaborating on development plans, regulatory interactions, and commercial evaluation of a Virology compound in one or more indications.
Key Responsibilities
- Provide statistical leadership to Virology clinical trials: develop trial design options and provide decision support.
- Act as statistical lead for a specific Virology molecule/indication in Health Authority interactions; maintain an accountability thread to TA head.
- Collaborate with Statistical Programming, Clinical Research, Clinical Data Management, Global Drug Safety, Regulatory, and Project Management to meet deliverables and timelines for statistical analysis/reporting.
- Apply regulatory requirements to ensure meeting regulatory, scientific, and business objectives.
- Collaborate with investigators, external experts, and internal colleagues to present and publish trial results/statistical analyses.
- Negotiate timelines under constraints; support long-term staffing plans and staff development; participate in strategic risk assessment.
- Oversee and contribute to technical/operational statistical activities for multiple development programs through internal/external resource management.
- Provide leadership for a departmental strategic initiative; directly supervise personnel.
Basic Qualifications
- PhD with 8+ years industry experience, OR
- Master’s with 10+ years, OR
- Bachelor’s with 12+ years.
Preferred Qualifications
- Hands-on drug development experience (trial design/analysis for phase 1-3); participation in NDA/BLA filing through label negotiation.
- Biomedical statistical analysis experience; SAS and R preferred.
- Strong verbal/written communication; ability to convey complex concepts clearly.
- Collaboration/interpersonal skills across diverse cross-functional teams.
- Holistic problem analysis; anticipates obstacles and proactively develops solutions.
- Ability to assemble/lead high-performing teams.
People Leader Accountabilities
- Create Inclusion; Develop Talent; Empower Teams.
Application Instructions
- Please apply via the Internal Career Opportunities portal in Workday.