Chief Biostatistics & Data Strategy Leader

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

Benefits offered by this job

401k plan

Medical insurance

Dental and vision

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Stock purchase plan

Vacation and holidays

Job summary

Exelixis is seeking a senior Biostatistics leader to develop and oversee statistics strategies, tools, and processes for clinical trial data integrity and efficiency. You will work with cross-functional teams and executives to shape drug development strategy and ensure regulatory compliance.

The role requires 15+ years in biostatistics with at least 8 years in management, PhD preferred, and extensive experience with FDA/EU regulatory expectations.

Qualifications

• PhD strongly preferred with 15+ years of biostatistics experience and 8+ years in progressive management roles.
• Experience leading biostatistics in oncology or pharmaceutical clinical trials units.
• Strong regulatory knowledge (FDA/EU) and ability to translate strategy into executable programs.

Responsibilities

• Lead development and oversight of biostatistics strategies, tools, and processes.
• Collaborate with executive leadership to set vision and manage risk for Biostatistics.
• Ensure staffing and growth of teams, including vendors and CROs, to meet project needs.
• Guide design, analysis, and interpretation of Phase I–IV trials and statistical analysis plans.

Skills

Biostatistics leadership

Regulatory experience (FDA/EU)

Strategic planning

Cross-functional collaboration

People management

Education

PhD in related discipline

MS/MA in related discipline

BA/BS in related discipline

Tools

SAS/R

Job description

Exelixis is seeking a senior Biostatistics leader to develop and oversee statistics strategies, tools, and processes for clinical trial data integrity and efficiency. You will work with cross-functional teams and executives to shape drug development strategy and ensure regulatory compliance.

The role requires 15+ years in biostatistics with at least 8 years in management, PhD preferred, and extensive experience with FDA/EU regulatory expectations.