Sr Biostatistics Director
Exelixis
August 26, 2026
Remote friendly (Alameda, CA)
United States
Clinical Research and Development
Summary/Job Purpose
- Provide leadership in biostatistics to develop and execute statistical strategy, design, and analyses for clinical trials in all phases, meeting objectives, health authority guidelines, and regulatory requirements.
- Partner in clinical development to set standards for clinical conduct and data collection/reporting; develop biostatistics policies and provide statistical/regulatory guidance.
- Represent biostatistics with IRBs/ethics committees/health agencies; manage CRO timelines, deliverables, and budgets.
Responsibilities
- Develop and implement department standards and practices.
- Direct statistical design, conduct, and analysis of clinical trials (all phases).
- Review protocols and case report forms; review/author statistical analysis plans.
- Analyze/interpret results; collaborate to produce interim reports, final reports, and publications.
- Develop integrated safety/efficacy summary content.
- Interact with FDA/EU authorities; attend meetings to ensure ongoing agreement.
- Contribute to RFP development.
- Evaluate/manage CROs and vendors (scope, timelines, deliverables, budgets).
- Provide statistical oversight within a therapeutic area.
Qualifications/Experience
- BS/BA (Statistics/Biostatistics or related) + 15 years; or MS/MA + 13 years; or PhD + 12 years; or equivalent.
- Managed/supported clinical trials (preferably oncology; biotech/pharma); preferably led Phase III.
- In-depth knowledge of CDISC; experience analyzing Phase I–IV data for US NDAs.
- Direct FDA/EU authority experience preferred.
- May require certification in assigned area.
Skills
- Strong knowledge of statistical experimental design/analyses and oncology trial requirements.
- Developed/reviewed SDTM/ADaM specifications.
- Proficiency with SAS, EAST, nQuery, Cytel Studio; strong analytical and communication skills.
- Project management and vendor contract negotiation.
Benefits (explicitly stated)
- Base pay range: $216,500–$307,500; 401(k) match, medical/dental/vision, life/disability, FSA, discretionary annual bonus/incentives, stock purchase, long-term incentives, vacation/holidays, sick days.
- Provide leadership in biostatistics to develop and execute statistical strategy, design, and analyses for clinical trials in all phases, meeting objectives, health authority guidelines, and regulatory requirements.
- Partner in clinical development to set standards for clinical conduct and data collection/reporting; develop biostatistics policies and provide statistical/regulatory guidance.
- Represent biostatistics with IRBs/ethics committees/health agencies; manage CRO timelines, deliverables, and budgets.
Responsibilities
- Develop and implement department standards and practices.
- Direct statistical design, conduct, and analysis of clinical trials (all phases).
- Review protocols and case report forms; review/author statistical analysis plans.
- Analyze/interpret results; collaborate to produce interim reports, final reports, and publications.
- Develop integrated safety/efficacy summary content.
- Interact with FDA/EU authorities; attend meetings to ensure ongoing agreement.
- Contribute to RFP development.
- Evaluate/manage CROs and vendors (scope, timelines, deliverables, budgets).
- Provide statistical oversight within a therapeutic area.
Qualifications/Experience
- BS/BA (Statistics/Biostatistics or related) + 15 years; or MS/MA + 13 years; or PhD + 12 years; or equivalent.
- Managed/supported clinical trials (preferably oncology; biotech/pharma); preferably led Phase III.
- In-depth knowledge of CDISC; experience analyzing Phase I–IV data for US NDAs.
- Direct FDA/EU authority experience preferred.
- May require certification in assigned area.
Skills
- Strong knowledge of statistical experimental design/analyses and oncology trial requirements.
- Developed/reviewed SDTM/ADaM specifications.
- Proficiency with SAS, EAST, nQuery, Cytel Studio; strong analytical and communication skills.
- Project management and vendor contract negotiation.
Benefits (explicitly stated)
- Base pay range: $216,500–$307,500; 401(k) match, medical/dental/vision, life/disability, FSA, discretionary annual bonus/incentives, stock purchase, long-term incentives, vacation/holidays, sick days.