Vice President, Biostatistics

Exelixis • Alameda, CA

383d • $339,500 - $394,500

About The Position

The position is responsible for the development and oversight of biostatistics and associated tools and processes to ensure efficient, accurate, and timely collection and analysis of clinical trial data. The role involves establishing company policies and practices in compliance with industry standards, participating in drug development strategy, and ensuring high standards of data integrity and quality.

Requirements

• BA/BS in a related discipline with a minimum of 21 years of relevant experience in the pharmaceutical industry; or MA/MS with 19 years; or PhD with 17 years; or equivalent combination of education and experience.
• At least 15 years of progressive experience in biostatistics, including 8 years in functional area management at senior director level.
• Thorough understanding of biostatistics in oncology and clinical trials.
• Successful track record managing clinical studies from Phase I - III for US NDA filings.
• Ability to translate strategy into implementation and inspire teams.

Nice To Haves

• Experience with Real World Data (RWD) access and analysis.
• Direct experience with FDA/EU regulatory authority.

Responsibilities

• Lead the development and implementation of biostatistics strategies aligned with company objectives.
• Interact with executive leadership to manage risk and influence departmental activities.
• Ensure appropriate staffing of functional areas with qualified personnel.
• Collaborate with project clinicians to design and analyze clinical protocols and statistical plans.
• Identify and implement statistical methods for regulatory and publication purposes.
• Develop relationships with cross-functional leaders in clinical, regulatory, and drug safety areas.
• Represent data science and biometrics on internal executive committees.
• Provide leadership for sponsor/CRO activities and manage relationships.
• Ensure compliance with regulatory requirements through interaction with FDA and other authorities.
• Oversee the development of best practices, SOPs, and policies for biostatistics processes.
• Manage budgets for the biostatistics department and CROs.

Benefits

• 401k plan with generous company contributions
• Group medical, dental, and vision coverage
• Life and disability insurance
• Flexible spending accounts
• Discretionary annual bonus program
• Opportunity to purchase company stock
• Long-term incentives
• 15 accrued vacation days in the first year
• 17 paid holidays including a winter shutdown
• Up to 10 sick days throughout the year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree