VP Biostatistics & Data Strategy (Equity Eligible)

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

Benefits offered by this job

401(k) plan

Medical coverage

Life insurance

Discretionary bonus

Stock options

Paid time off

Holidays

Job summary

Exelixis Inc is seeking a senior biostatistics leader to oversee development and governance of biostatistics strategy, tools and processes for clinical trial data. You will ensure data integrity and regulatory readiness while shaping drug development direction.

The role partners with executive teams, vendors and CROs to design studies, oversee regulatory submissions, and drive efficiency. Strong leadership, FDA/EU experience, and a track record of delivering Phase I–III programs are essential.

Qualifications

• PhD or equivalent in biostatistics with extensive pharma industry experience.
• Proven track record of leading biostatistics teams and delivering regulatory submissions.
• Strong leadership and communication across cross-functional teams.

Responsibilities

• Lead development and implementation of biostatistics strategies aligned with corporate objectives.
• Interact with executive leadership to set vision and manage risk for Biostatistics.
• Ensure staffing for critical work across departments.
• Collaborate with project clinicians to design and analyze Phase I–IV trials.
• Advise on regulatory submissions and data presentation methods.
• Provide statistical leadership for Real-World Data analysis.
• Set up and maintain methodological teams and budget planning.

Skills

Biostatistics leadership

Regulatory knowledge

Statistical methods

Cross-functional collaboration

FDA interactions

Team management

Education

PhD in Biostatistics

MS in Biostatistics

Tools

SAS

R

Regulatory analytics tools

Job description

Exelixis Inc is seeking a senior biostatistics leader to oversee development and governance of biostatistics strategy, tools and processes for clinical trial data. You will ensure data integrity and regulatory readiness while shaping drug development direction.

The role partners with executive teams, vendors and CROs to design studies, oversee regulatory submissions, and drive efficiency. Strong leadership, FDA/EU experience, and a track record of delivering Phase I–III programs are essential.