Biostatistics Manager
Exelixis
June 30, 2026
Remote friendly (Alameda, CA)
United States
Clinical Research and Development
Summary/Job Purpose
Designs, plans and executes biostatistical components of R&D project plans to determine safety, efficacy and marketability of compounds. Prepares the statistical component of protocols that meet project objectives, guidelines and clinical trial methodology standards.
Responsibilities
- Provide written and verbal recommendations on quantitative/statistical and data management issues.
- Develop clinical protocol statistical components: review CRFs, CRF edit checks and completion guidelines; author statistical analysis plan and TLF shells/table of contents; review ADaM specifications and verify primary/secondary efficacy endpoints.
- Assist with data analysis and interpretation; may collaborate on interim reports, final reports, and publications.
- Interact with/manage counterparts at CROs or collaborating companies.
- Interpret regulatory guideline implications for the project.
Qualifications (Education/Experience)
- BS/BA in related discipline + 7 years; or MS/MA + 5 years; or PhD + 0+ years; or equivalent combination.
- Typically requires a minimum of 3 years of related experience and/or combination of experience and education/training.
- May require certification in assigned area.
Skills/Knowledge (Preferred/Required)
- Preferred: SAS and/or R programming.
- Developed/reviewed SDTM/ADaM specifications.
- Experience in Oncology or similar discipline.
- Knowledge of FDA/EMA regulations and guidance.
- Statistical judgment, problem solving, attention to detail.
- Ability to represent Biostatistics in multidisciplinary meetings and interact with CRO/clinical/data teams.
Benefits (as listed)
401(k) with generous company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive); opportunity to purchase company stock; long-term incentives; 15 vacation days (first year); 17 paid holidays including winter shutdown; up to 10 sick days.
Application instructions (if accommodation needed)
Email: recruiting@exelixis.com.
Designs, plans and executes biostatistical components of R&D project plans to determine safety, efficacy and marketability of compounds. Prepares the statistical component of protocols that meet project objectives, guidelines and clinical trial methodology standards.
Responsibilities
- Provide written and verbal recommendations on quantitative/statistical and data management issues.
- Develop clinical protocol statistical components: review CRFs, CRF edit checks and completion guidelines; author statistical analysis plan and TLF shells/table of contents; review ADaM specifications and verify primary/secondary efficacy endpoints.
- Assist with data analysis and interpretation; may collaborate on interim reports, final reports, and publications.
- Interact with/manage counterparts at CROs or collaborating companies.
- Interpret regulatory guideline implications for the project.
Qualifications (Education/Experience)
- BS/BA in related discipline + 7 years; or MS/MA + 5 years; or PhD + 0+ years; or equivalent combination.
- Typically requires a minimum of 3 years of related experience and/or combination of experience and education/training.
- May require certification in assigned area.
Skills/Knowledge (Preferred/Required)
- Preferred: SAS and/or R programming.
- Developed/reviewed SDTM/ADaM specifications.
- Experience in Oncology or similar discipline.
- Knowledge of FDA/EMA regulations and guidance.
- Statistical judgment, problem solving, attention to detail.
- Ability to represent Biostatistics in multidisciplinary meetings and interact with CRO/clinical/data teams.
Benefits (as listed)
401(k) with generous company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive); opportunity to purchase company stock; long-term incentives; 15 vacation days (first year); 17 paid holidays including winter shutdown; up to 10 sick days.
Application instructions (if accommodation needed)
Email: recruiting@exelixis.com.