Responsibilities:
- Provide strategic and operational statistical leadership for clinical development programs (Phase 1β3).
- Serve as lead statistician with responsibility for overall statistical strategy and delivery.
- Act as biostatistics lead for clinical studies and non-molecule projects.
- Represent Biostatistics on study management/development teams; collaborate cross-functionally.
- Consult on study design, endpoints, analysis methods, and statistical analysis plans (SAPs/TFLs/CSR review).
- Lead technical/operational statistical activities for groups of trials; direct internal/external teams.
- Contribute to cross-functional clinical planning and protocol development.
- Advise on statistical analysis strategies, measurement reliability, model identifiability, and interpretation/presentation.
- Review/analyze safety reporting, biomarker analyses, and trial monitoring for development decisions.
- Use advanced statistical software/methods to analyze historical/external data.
- Provide input to clinical documentation, publications/presentations, and regulatory documentation.
Basic Qualifications:
- Bachelorβs + 10 years OR Masterβs + 8 years OR PhD/PharmD + 5 years.
Preferred Qualifications/Skills:
- Rapid assimilation of scientific/statistical information; adaptability across projects.
- Advanced biomedical statistical analysis knowledge; biostatistics best practices/tools.
- Strategic advising skills; solid understanding of drug development phases/clinical trials.
- Knowledge of FDA/EMA, ICH, GCP; strong written/verbal, collaboration, organizational skills.
- Preferred: HBV/HIV experience; innovative trial designs; effective project/team management.
People Leader Accountabilities:
- Create Inclusion, Develop Talent, Empower Teams.
Compensation/Benefits (if applicable):
- Salary range: Bay Area $195,670β$253,220; Other US $177,905β$230,230. May include discretionary bonus/long-term incentives, paid time off, and medical/dental/vision/life.
Application Instructions:
- For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.