VP Biostatistics & Data Strategy

Exelixis, Inc.; Alameda (CA); On-site; USD 360,000 - 418,000; Full time

Benefits offered by this job

401k plan with company contributions

Comprehensive medical/dental/vision

Job summary

Exelixis, Inc. seeks a Senior Biostatistics leader to oversee strategy, operations, and personnel for oncology trials. You will shape statistical methods, ensure data integrity, and liaise with FDA/EU regulators, CROs, and cross-functional teams.

You will guide Phase I–IV analyses, budgets, and vendor oversight, while driving efficiency through SOPs and best practices. Strong leadership and communication are essential.

Qualifications

• PhD preferred with strong biostatistics leadership and pharmaceutical industry expertise.
• Experience guiding biostatistics strategy for oncology programs.
• Experience interacting with FDA/EU regulators and cross-functional partners.
• Proven ability to manage complex clinical programs (Phase I–III) and NDA support.

Responsibilities

• Lead biostatistics strategy and operations across oncology programs.
• Oversee development and implementation of SOPs, tools, and processes.
• Interact with executive leadership and regulatory authorities; manage vendor relationships.
• Provide executive statistical leadership for sponsor/CRO activities and RWD analyses.
• Direct supervision of biostatistics staff and cross-functional teams.

Education

PhD in related discipline

MD/DO or PhD in related discipline

Extensive biostatistics leadership experience

Regulatory collaboration experience (FDA/EU)

Job description

Exelixis, Inc. seeks a Senior Biostatistics leader to oversee strategy, operations, and personnel for oncology trials. You will shape statistical methods, ensure data integrity, and liaise with FDA/EU regulators, CROs, and cross-functional teams.

You will guide Phase I–IV analyses, budgets, and vendor oversight, while driving efficiency through SOPs and best practices. Strong leadership and communication are essential.