Vice President, Biostatistics
Exelixis
August 18, 2026
On-site
Alameda, CA
Clinical Research and Development
Summary/Job Purpose
Responsible for the development and oversight of biostatistics and associated tools/process strategies, operations, and personnel to ensure efficient, accurate, and timely collection and analysis of clinical trial data with high data integrity and quality. Develops and implements biostatistics policies, practices, and operating procedures in compliance with industry standards; contributes to drug development strategy.
Essential Duties and Responsibilities
- Lead development and implementation of biostatistics strategies aligned to company objectives; ensure overall operations of biostatistics tools and processes.
- Partner with executive leadership to set vision, execute decisions, manage risk, and influence long-term viability of the biostatistics function.
- Ensure appropriate resourcing and development of employees/consultants/workers.
- Work with project clinicians to design, develop, conduct, and analyze Phase I–IV protocols and statistical analysis plans.
- Implement statistical and data-presentation methods for regulatory and publication needs.
- Collaborate with cross-functional leaders (clinical, regulatory, drug safety, and peers).
- Serve as a DSB representative on executive committees (protocol/clinical document review, strategic/partner joint development, drug safety).
- Provide executive leadership for sponsor/CRO activities, relationships, and escalation resolution.
- Interact with FDA and other regulatory authorities to ensure regulatory compliance.
- Oversee best practices, SOPs/standards/work instructions, including novel approaches to improve efficiency, quality, and reduce costs/timelines.
- Select and manage key opinion leaders (KoLs), academic relationships, CROs, and critical vendors.
- Provide statistical leadership for Real-World Data (RWD) access and analysis; build/maintain the methodological team and guide the organization.
- Develop and maintain biostatistics/CRO budgets within corporate fiscal targets.
Supervisory Responsibilities
- Directly supervise employees; indirectly supervise via subordinate management.
Education/Experience/Knowledge & Skills
- BA/BS + 21+ years pharmaceutical industry experience; or MA/MS + 19+; or PhD + 17+; or equivalent combination.
Ideal Qualifications (Required/Preferred)
- PhD strongly preferred.
- 15+ years progressive biostatistics experience, including 8+ years progressive functional area management through senior director level.
- Strong oncology biostatistics/clinical trials understanding.
- Track record managing Phase I–III clinical studies supporting US NDA filings.
- Proven strategy-to-execution and results/milestone delivery.
- Ability to articulate vision and motivate teams.
- Demonstrated collaboration with executives, advisory committees, peers, subordinates, and project teams.
- Ability to deliver performance measures.
- Direct experience with FDA/EU regulatory authorities.
Benefits (as stated)
- 401(k) with generous company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive if field sales); stock purchase; long-term incentives; 15 vacation days; 17 paid holidays (winter shutdown in December); up to 10 sick days.
Application Instructions
- For disability accommodations during recruiting: ApplicantAccommodations@exelixis.com
Responsible for the development and oversight of biostatistics and associated tools/process strategies, operations, and personnel to ensure efficient, accurate, and timely collection and analysis of clinical trial data with high data integrity and quality. Develops and implements biostatistics policies, practices, and operating procedures in compliance with industry standards; contributes to drug development strategy.
Essential Duties and Responsibilities
- Lead development and implementation of biostatistics strategies aligned to company objectives; ensure overall operations of biostatistics tools and processes.
- Partner with executive leadership to set vision, execute decisions, manage risk, and influence long-term viability of the biostatistics function.
- Ensure appropriate resourcing and development of employees/consultants/workers.
- Work with project clinicians to design, develop, conduct, and analyze Phase I–IV protocols and statistical analysis plans.
- Implement statistical and data-presentation methods for regulatory and publication needs.
- Collaborate with cross-functional leaders (clinical, regulatory, drug safety, and peers).
- Serve as a DSB representative on executive committees (protocol/clinical document review, strategic/partner joint development, drug safety).
- Provide executive leadership for sponsor/CRO activities, relationships, and escalation resolution.
- Interact with FDA and other regulatory authorities to ensure regulatory compliance.
- Oversee best practices, SOPs/standards/work instructions, including novel approaches to improve efficiency, quality, and reduce costs/timelines.
- Select and manage key opinion leaders (KoLs), academic relationships, CROs, and critical vendors.
- Provide statistical leadership for Real-World Data (RWD) access and analysis; build/maintain the methodological team and guide the organization.
- Develop and maintain biostatistics/CRO budgets within corporate fiscal targets.
Supervisory Responsibilities
- Directly supervise employees; indirectly supervise via subordinate management.
Education/Experience/Knowledge & Skills
- BA/BS + 21+ years pharmaceutical industry experience; or MA/MS + 19+; or PhD + 17+; or equivalent combination.
Ideal Qualifications (Required/Preferred)
- PhD strongly preferred.
- 15+ years progressive biostatistics experience, including 8+ years progressive functional area management through senior director level.
- Strong oncology biostatistics/clinical trials understanding.
- Track record managing Phase I–III clinical studies supporting US NDA filings.
- Proven strategy-to-execution and results/milestone delivery.
- Ability to articulate vision and motivate teams.
- Demonstrated collaboration with executives, advisory committees, peers, subordinates, and project teams.
- Ability to deliver performance measures.
- Direct experience with FDA/EU regulatory authorities.
Benefits (as stated)
- 401(k) with generous company contributions; medical/dental/vision; life/disability; flexible spending accounts; discretionary annual bonus (or sales incentive if field sales); stock purchase; long-term incentives; 15 vacation days; 17 paid holidays (winter shutdown in December); up to 10 sick days.
Application Instructions
- For disability accommodations during recruiting: ApplicantAccommodations@exelixis.com