Lead Biostatistics Director, Clinical Trials Strategy

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

Benefits offered by this job

401(k) plan

Medical, dental, and vision coverage

Discretionary annual bonus

Stock options

Paid holidays

Job summary

Exelixis in Alameda, CA, USA seeks a leader in biostatistics to develop and execute statistical strategy for clinical trials across all phases. You will design analyses, guide regulatory interactions, and manage external partners to advance oncology programs with strong methodological rigor.

The role requires extensive experience in CDISC, FDA/EU guidelines, and cross-functional collaboration, ensuring timely deliverables and high-quality statistical outputs for NDA submissions.

Qualifications

• BS/BA in Statistics/Biostatistics or related field with 15+ years of experience
• MS/MA in Statistics/Biostatistics or related field with 13+ years of experience
• PhD in Statistics/Biostatistics or related field with 12+ years of experience
• Equivalent combination of education and experience
• Certification in assigned area may be required

Responsibilities

• Direct the statistical design, conduct, and analysis of clinical trials in all phases
• Review protocols and case report forms for soundness of trial design
• Review and/or author statistical analysis plans for all phases
• Perform analysis, interpret results, and collaborate with clinical team to produce reports
• Develop, validate and summarize integrated safety and efficacy summaries
• Interact with FDA or EU Authority staff to ensure regulatory requirements are met
• Attend meetings with FDA or EU Authority for project alignment
• Contribute to RFP development
• Evaluate and manage CROs and other vendors including scope, timelines, and budgets
• Provide statistical oversight within a therapeutic area

Skills

Statistics

Biostatistics

CDISC standards

FDA/EU guidelines

SAS

Data analysis

Project management

Education

BS/BA in Statistics/Biostatistics

MS/MA in Statistics/Biostatistics

PhD in Statistics/Biostatistics

Equivalent edu/experience

Certification in assigned area

Tools

SAS

EAST

nQuery

Cytel Studio

Job description

Exelixis in Alameda, CA, USA seeks a leader in biostatistics to develop and execute statistical strategy for clinical trials across all phases. You will design analyses, guide regulatory interactions, and manage external partners to advance oncology programs with strong methodological rigor.

The role requires extensive experience in CDISC, FDA/EU guidelines, and cross-functional collaboration, ensuring timely deliverables and high-quality statistical outputs for NDA submissions.