Senior Biostatistics Director, Oncology Strategy

Exelixis; Alameda (CA); On-site; USD 217,000 - 308,000; Full time

Benefits offered by this job

401(k) plan

Medical, dental, vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary bonus program

Employee stock purchase plan

Job summary

Exelixis is seeking a senior biostatistics leader to design and execute statistical strategy for clinical trials across all phases. The role collaborates with clinical teams to frame study design, analysis plans, and regulatory submissions, ensuring alignment with health authority guidelines.

This position manages CROs, timelines, budgets, and delivers strategic statistical guidance to mitigate risk. The candidate will work closely with FDA/EU authorities and contribute to standard-setting in

Qualifications

• Requires BS/BA with 15+ years, MS with 13+ years, or PhD with 12+ years in statistics/biostatistics.

Responsibilities

• Direct statistical design, conduct, and analysis of clinical trials in all phases.
• Review protocols and CRFs for sound trial design.
• Prepare and review statistical analysis plans for all trial phases.
• Interact with FDA/EU authorities to ensure regulatory compliance.
• Oversee CROs, timelines, budgets, and vendor deliverables.
• Develop and implement biostatistics standards and policies.

Skills

Statistical design

Regulatory knowledge

Data analysis

Clinical trial experience

Education

BS/BA in Statistics/Biostatistics

MS/MA in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Equivalent combination of education and experience

Tools

SAS

EAST

nQuery

Cytel Studio

Job description

Exelixis is seeking a senior biostatistics leader to design and execute statistical strategy for clinical trials across all phases. The role collaborates with clinical teams to frame study design, analysis plans, and regulatory submissions, ensuring alignment with health authority guidelines.

This position manages CROs, timelines, budgets, and delivers strategic statistical guidance to mitigate risk. The candidate will work closely with FDA/EU authorities and contribute to standard-setting in