Responsibilities:
- Provide strategic and operational statistical leadership for clinical development programs.
- Serve as lead statistician for Phase 1β3 clinical trials; own overall statistical strategy and delivery.
- Act as biostatistics lead for clinical studies or other non-molecule projects.
- Represent Biostatistics on study management and development teams; partner with Clinical Development, Patient Safety, Clinical Pharmacology, Regulatory Affairs, Project Management, Programming, and Clinical Data Management.
- Provide statistical consultation for study design, endpoints, and analysis methods; contribute to protocol, SAP/TFL/CSR review, and scientific/regulatory deliverables.
- Oversee technical and operational statistical activities for a group of clinical trials; direct internal/external teams.
- Advise on statistical analysis strategies, measurement reliability, model identifiability, and interpretation/presentation of results.
- Review/analyze safety reporting, biomarker analyses, and trial monitoring inputs to inform decisions.
- Use advanced statistical software/methods to analyze historical/external data for clinical development.
- Participate/lead special projects and contribute to SOP/process development.
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 expertise; biostatistics best practices.
- Strategic thinking; solid understanding of drug development phases and trial structure.
- Knowledge of FDA/EMA, ICH, GCP; strong written/verbal communication and collaboration.
- Experience in HBV/HIV programs preferred; familiar with innovative trial designs.
Comp/Benefits (if applicable):
- Bay Area: $195,670β$253,220; Other US: $177,905β$230,230. May be eligible for discretionary annual bonus, stock-based long-term incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application Instructions:
- For current Gilead employees/contractors: apply via the Internal Career Opportunities portal in Workday.