Director, Biostatistics
Gilead Sciences
June 27, 2026
Remote friendly (San Francisco Bay Area)
United States
Clinical Research and Development
Key Responsibilities
- Provide statistical leadership to late-stage oncology clinical trials: develop trial design options and provide decision support.
- Serve as statistical lead for an oncology molecule/indication in Health Authority interactions; maintain an accountability thread to TA head.
- Collaborate with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers, and Clinical/Global Drug Safety/Regulatory/Project Management teams to meet statistical analysis and reporting deliverables and timelines.
- Direct internal and external multifunctional teams; lead initiatives to gather, organize, and analyze data (e.g., virology, Case Report Forms, patient tracking). Defend statistical aspects with regulatory agencies; develop staff capabilities.
- Oversee and contribute to completion of technical and operational statistical activities for a group of clinical trials (compound/indication) via internal/external resourcing.
- Lead two or more components of departmental strategic initiatives.
Qualifications & Experience
- 12+ years (BS); 10+ years (MS); 8+ years (PhD) statistical analysis experience in pharma/biotech (or CRO).
- Industry experience analyzing biomedical data using statistical software.
- Extensive hands-on oncology drug development experience, including design/analysis of phase 3 trials; participation in NDA/BLA filing through label negotiation.
- Effective verbal/written communication and interpersonal skills.
- Ability to evaluate functional issues broadly and determine critical functions for company success.
- Anticipates obstacles; leads effective teams; communicates science within/outside the company.
People Leader Accountabilities
- Create Inclusion; Develop Talent; Empower Teams.
- Provide statistical leadership to late-stage oncology clinical trials: develop trial design options and provide decision support.
- Serve as statistical lead for an oncology molecule/indication in Health Authority interactions; maintain an accountability thread to TA head.
- Collaborate with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers, and Clinical/Global Drug Safety/Regulatory/Project Management teams to meet statistical analysis and reporting deliverables and timelines.
- Direct internal and external multifunctional teams; lead initiatives to gather, organize, and analyze data (e.g., virology, Case Report Forms, patient tracking). Defend statistical aspects with regulatory agencies; develop staff capabilities.
- Oversee and contribute to completion of technical and operational statistical activities for a group of clinical trials (compound/indication) via internal/external resourcing.
- Lead two or more components of departmental strategic initiatives.
Qualifications & Experience
- 12+ years (BS); 10+ years (MS); 8+ years (PhD) statistical analysis experience in pharma/biotech (or CRO).
- Industry experience analyzing biomedical data using statistical software.
- Extensive hands-on oncology drug development experience, including design/analysis of phase 3 trials; participation in NDA/BLA filing through label negotiation.
- Effective verbal/written communication and interpersonal skills.
- Ability to evaluate functional issues broadly and determine critical functions for company success.
- Anticipates obstacles; leads effective teams; communicates science within/outside the company.
People Leader Accountabilities
- Create Inclusion; Develop Talent; Empower Teams.