Sr Director, Biostatistics
Exelixis
August 20, 2026
Remote friendly (Alameda, CA)
United States
Clinical Research and Development
Summary/Job Purpose
- Provides leadership to the biostatistics function and direct management of biostatistics staff to develop statistical strategy, design, and analyses for early phase (1/2) clinical trials for multiple compounds.
- Sets direction for statistical support of translational medicine and clinical biomarkers; applies sound statistical methodology to meet early development objectives.
Essential Duties And Responsibilities
- Responsible for all statistical oversight of early development projects.
- Provide strategic input on early development clinical development programs.
- Provide critical input on translational medicine and clinical biomarker strategy.
- Lead development/implementation of department standards, practices, and process-improvement initiatives.
- Provide technical oversight of statistical design, conduct, and analysis of early phase clinical trials; review protocols, statistical analysis plans, and case report forms.
- Recruit, develop, and supervise biostatisticians; lead teams with responsibility for results, costs, methods, and resourcing.
- Interact with FDA or EU Authority staff to ensure regulatory requirements.
- Contribute to RFPs for CROs/vendors; evaluate/manage CROs/vendors (scope, timelines, deliverables, budgets).
Supervisory Responsibilities
- Direct management and supervision of biostatisticians (and indirect supervision via dotted-line structure).
Education/Experience
- MS/MA in Statistics/Biostatistics (or related) + 13+ years; or PhD + 12+ years; or equivalent oncology experience.
Requirements/Ideal
- 5+ years oncology trial management (and 10+ years other therapeutic areas); led Phase 1 and Phase 2 oncology studies.
- Experience with clinical biomarkers and large genetics/omics datasets; manage multiple statisticians.
- Knowledge of FDA/EMA/ICH guidelines; CDISC standards; experience with FDA/EU interaction preferred.
Skills
- People management; communication/conflict management.
- Strong knowledge of statistical experimental designs/analyses and early development oncology trial requirements.
- Functional understanding of data management, clinical operations, clinical science, regulatory affairs, and drug safety; vendor/project management.
Benefits (as stated)
- Comprehensive employee benefits: 401k with company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive for field sales); stock purchase; 15 vacation days (first year); 17 paid holidays incl. winter shutdown; up to 10 sick days.
- Provides leadership to the biostatistics function and direct management of biostatistics staff to develop statistical strategy, design, and analyses for early phase (1/2) clinical trials for multiple compounds.
- Sets direction for statistical support of translational medicine and clinical biomarkers; applies sound statistical methodology to meet early development objectives.
Essential Duties And Responsibilities
- Responsible for all statistical oversight of early development projects.
- Provide strategic input on early development clinical development programs.
- Provide critical input on translational medicine and clinical biomarker strategy.
- Lead development/implementation of department standards, practices, and process-improvement initiatives.
- Provide technical oversight of statistical design, conduct, and analysis of early phase clinical trials; review protocols, statistical analysis plans, and case report forms.
- Recruit, develop, and supervise biostatisticians; lead teams with responsibility for results, costs, methods, and resourcing.
- Interact with FDA or EU Authority staff to ensure regulatory requirements.
- Contribute to RFPs for CROs/vendors; evaluate/manage CROs/vendors (scope, timelines, deliverables, budgets).
Supervisory Responsibilities
- Direct management and supervision of biostatisticians (and indirect supervision via dotted-line structure).
Education/Experience
- MS/MA in Statistics/Biostatistics (or related) + 13+ years; or PhD + 12+ years; or equivalent oncology experience.
Requirements/Ideal
- 5+ years oncology trial management (and 10+ years other therapeutic areas); led Phase 1 and Phase 2 oncology studies.
- Experience with clinical biomarkers and large genetics/omics datasets; manage multiple statisticians.
- Knowledge of FDA/EMA/ICH guidelines; CDISC standards; experience with FDA/EU interaction preferred.
Skills
- People management; communication/conflict management.
- Strong knowledge of statistical experimental designs/analyses and early development oncology trial requirements.
- Functional understanding of data management, clinical operations, clinical science, regulatory affairs, and drug safety; vendor/project management.
Benefits (as stated)
- Comprehensive employee benefits: 401k with company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive for field sales); stock purchase; 15 vacation days (first year); 17 paid holidays incl. winter shutdown; up to 10 sick days.