Executive Director, Biostatistics
Exelixis
August 19, 2026
On-site
Alameda, CA
Clinical Research and Development
Summary/Job Purpose:
Leads the biostatistics function developing statistical strategy, design, and analyses for clinical trials in all phases for multiple compounds; provides statistical and regulatory guidance and oversees statistical oversight in support of NDAs.
Essential Duties & Responsibilities:
- Provide vision/direction for biostatistics standards, practices, and process improvements.
- Provide strategic input to clinical development programs; provide technical oversight of statistical design, conduct, and analysis for all trial phases.
- Review protocols, case report forms, and statistical analysis plans.
- Direct analysis, interpret results, and collaborate to deliver interim/final reports, safety updates, and publications.
- Lead/manage project work and supervise biostatisticians; manage delivery, costs, methods, and staffing.
- Manage statistical analysis of Phase I–IV clinical study data for NDAs.
- Interact with FDA/EU authorities; attend regulatory meetings.
- Lead RFP development and evaluate/manage CROs and vendors (SOW, timelines, deliverables, budgets).
- Interpret/execute/recommend policy modifications and lead standardization across biostatistics.
Supervisory Responsibilities:
- Supervise biostatisticians (and indirectly supervise other staff via dotted lines).
Education/Experience (Required):
- MS/MA (Statistics/Biostatistics or related) + 16 years; or PhD + 15 years; or equivalent oncology experience. May require certification.
Experience (Preferred):
- Oncology clinical trials leadership (5+ years oncology; 10+ other areas); led Phase 1–4 (prefer Phase 3). Supervised multiple statisticians. Direct FDA/EU experience preferred.
Skills/Knowledge (Required/Preferred):
- FDA/EMA/ICH drug development and statistical guidelines; CDISC standards; knowledge of SDTM/ADaM specs.
- Statistical software experience: SAS, EAST, nQuery, Cytel Studio.
- People management, communication, conflict management; strong statistical experimental design/clinical trial expertise.
Benefits (as stated):
- 401k with generous company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive for field); stock purchase; 15 vacation days (first year), 17 paid holidays (incl. winter shutdown), up to 10 sick days.
Application Instruction:
- Accommodation request email: recruiting@exelixis.com.
Leads the biostatistics function developing statistical strategy, design, and analyses for clinical trials in all phases for multiple compounds; provides statistical and regulatory guidance and oversees statistical oversight in support of NDAs.
Essential Duties & Responsibilities:
- Provide vision/direction for biostatistics standards, practices, and process improvements.
- Provide strategic input to clinical development programs; provide technical oversight of statistical design, conduct, and analysis for all trial phases.
- Review protocols, case report forms, and statistical analysis plans.
- Direct analysis, interpret results, and collaborate to deliver interim/final reports, safety updates, and publications.
- Lead/manage project work and supervise biostatisticians; manage delivery, costs, methods, and staffing.
- Manage statistical analysis of Phase I–IV clinical study data for NDAs.
- Interact with FDA/EU authorities; attend regulatory meetings.
- Lead RFP development and evaluate/manage CROs and vendors (SOW, timelines, deliverables, budgets).
- Interpret/execute/recommend policy modifications and lead standardization across biostatistics.
Supervisory Responsibilities:
- Supervise biostatisticians (and indirectly supervise other staff via dotted lines).
Education/Experience (Required):
- MS/MA (Statistics/Biostatistics or related) + 16 years; or PhD + 15 years; or equivalent oncology experience. May require certification.
Experience (Preferred):
- Oncology clinical trials leadership (5+ years oncology; 10+ other areas); led Phase 1–4 (prefer Phase 3). Supervised multiple statisticians. Direct FDA/EU experience preferred.
Skills/Knowledge (Required/Preferred):
- FDA/EMA/ICH drug development and statistical guidelines; CDISC standards; knowledge of SDTM/ADaM specs.
- Statistical software experience: SAS, EAST, nQuery, Cytel Studio.
- People management, communication, conflict management; strong statistical experimental design/clinical trial expertise.
Benefits (as stated):
- 401k with generous company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive for field); stock purchase; 15 vacation days (first year), 17 paid holidays (incl. winter shutdown), up to 10 sick days.
Application Instruction:
- Accommodation request email: recruiting@exelixis.com.