Biostatistics Director
Exelixis
5 hours ago
Remote friendly (Alameda, CA)
United States
$188,000 - $266,500 USD yearly
Clinical Research and Development
Provides leadership within biostatistics to develop and execute statistical strategy, design, and analyses for clinical trials in all phases. Applies statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements. Develops/applies statistical theories, methods, and software. Partners in clinical development, study design, and standards for clinical conduct and data collection/management/reporting. Develops biostatistics policies, standards, practices, and work instructions. Provides strategic statistical/regulatory guidance, represents biostatistics with IRBs/ethics committees/health agencies, and manages CRO timelines, deliverables, and budgets.
Responsibilities:
- Work with department head to develop and implement department standards and practices.
- Direct statistical design, conduct, and analysis of clinical trials (all phases).
- Review protocols and case report forms for trial design soundness.
- Review and/or author statistical analysis plans for all phases.
- Perform analysis, interpret results, and collaborate to produce interim/final reports and publications.
- Direct development, validation, and summary of integrated safety and efficacy summaries.
- Interact with FDA/EU authorities to ensure regulatory compliance; attend meetings to maintain agreement on project development.
- Contribute to development of Requests-for-Proposals.
- Evaluate and manage CROs and vendors (scope, timelines, deliverables, budgets).
- Provide statistical oversight within a therapeutic area.
Supervisory Responsibilities:
- None.
Qualifications:
- BS/BA in Statistics/Biostatistics (or related) + 13+ years; or MS/MA + 11+ years; or PhD + 8+ years (or equivalent education/experience).
- May require certification in assigned area.
Preferred/Ideal Experience:
- Managed/supported clinical trials, preferably oncology and biotech/pharma.
- Preferably led a Phase III trial.
- In-depth knowledge of CDISC standards.
- Experience analyzing Phase I–IV data for US NDAs.
- Direct FDA/EU authority experience preferred.
- Typically requires 15+ years related experience (or combination of education/experience).
Knowledge/Skills:
- Advanced knowledge of statistical experimental design/analyses and clinical trial requirements (oncology).
- Developed/reviewed SDTM/ADaM specifications.
- Excellent knowledge of FDA/EU statistical guidelines.
- State-of-the-art data organization and statistical analysis using SAS, EAST, nQuery, Cytel Studio (or similar).
- Understands related disciplines (data management, clinical operations/science, regulatory affairs, drug safety).
- Project management and contract/vendor negotiation.
- Strong analytical and business communication skills.
Benefits (explicitly stated):
- Base pay range: $188,000–$266,500 annually.
- 401k with generous company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive plan for field sales).
- Stock purchase and long-term incentives; 15 vacation days (first year); 17 paid holidays including winter shutdown in December; up to 10 sick days/year.
Responsibilities:
- Work with department head to develop and implement department standards and practices.
- Direct statistical design, conduct, and analysis of clinical trials (all phases).
- Review protocols and case report forms for trial design soundness.
- Review and/or author statistical analysis plans for all phases.
- Perform analysis, interpret results, and collaborate to produce interim/final reports and publications.
- Direct development, validation, and summary of integrated safety and efficacy summaries.
- Interact with FDA/EU authorities to ensure regulatory compliance; attend meetings to maintain agreement on project development.
- Contribute to development of Requests-for-Proposals.
- Evaluate and manage CROs and vendors (scope, timelines, deliverables, budgets).
- Provide statistical oversight within a therapeutic area.
Supervisory Responsibilities:
- None.
Qualifications:
- BS/BA in Statistics/Biostatistics (or related) + 13+ years; or MS/MA + 11+ years; or PhD + 8+ years (or equivalent education/experience).
- May require certification in assigned area.
Preferred/Ideal Experience:
- Managed/supported clinical trials, preferably oncology and biotech/pharma.
- Preferably led a Phase III trial.
- In-depth knowledge of CDISC standards.
- Experience analyzing Phase I–IV data for US NDAs.
- Direct FDA/EU authority experience preferred.
- Typically requires 15+ years related experience (or combination of education/experience).
Knowledge/Skills:
- Advanced knowledge of statistical experimental design/analyses and clinical trial requirements (oncology).
- Developed/reviewed SDTM/ADaM specifications.
- Excellent knowledge of FDA/EU statistical guidelines.
- State-of-the-art data organization and statistical analysis using SAS, EAST, nQuery, Cytel Studio (or similar).
- Understands related disciplines (data management, clinical operations/science, regulatory affairs, drug safety).
- Project management and contract/vendor negotiation.
- Strong analytical and business communication skills.
Benefits (explicitly stated):
- Base pay range: $188,000–$266,500 annually.
- 401k with generous company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts.
- Discretionary annual bonus (or sales-based incentive plan for field sales).
- Stock purchase and long-term incentives; 15 vacation days (first year); 17 paid holidays including winter shutdown in December; up to 10 sick days/year.