Job Title: Biostatistics Director
Location: Alameda, CA / King of Prussia, PA
Job ID: JR6077
Employment Type: Full-time
Summary / Job Purpose:
The Biostatistics Director provides leadership in statistical strategy, trial design, and data analysis for clinical trials across all phases. This role ensures adherence to regulatory requirements, contributes to clinical program development, and manages relationships with regulatory bodies and vendors. The Director also helps shape departmental policies and best practices to support project success.
Essential Duties and Responsibilities:
Develop and implement biostatistics department standards and practices in collaboration with the department head.
Lead statistical aspects of clinical trial design, conduct, and analysis across all trial phases.
Review clinical protocols and case report forms to ensure robust trial design.
Author and review statistical analysis plans (SAPs).
Analyze data, interpret results, and partner with clinical teams to generate study reports and publications.
Lead the creation of integrated summaries for safety and efficacy.
Engage with FDA/EU authorities to ensure regulatory compliance.
Attend meetings with health authorities to maintain project alignment.
Assist in RFP creation and evaluation.
Oversee and manage CROs and vendors, including contracts, timelines, and budgets.
Serve as the primary statistical authority within assigned therapeutic areas.
Supervisory Responsibilities:
This position does not have direct supervisory responsibilities.
Education and Experience Requirements:
Bachelor’s Degree in Statistics/Biostatistics + 13+ years of relevant experience
Master’s Degree in Statistics/Biostatistics + 11+ years of relevant experience
PhD in Statistics/Biostatistics + 8+ years of relevant experience
Equivalent combinations of education and experience considered
Preferred Experience:
Leadership in Phase III clinical trials, preferably within oncology.
CDISC standards and experience with NDAs.
Direct experience with FDA/EU health authorities.
Strong knowledge of clinical trials in biotech/pharma industry.
Knowledge, Skills & Abilities:
Deep understanding of clinical trial design, statistical analysis, and oncology trials.
Proven ability in SDTM/ADaM specification review and development.
Proficient in SAS, EAST, nQuery, Cytel Studio.
Familiarity with FDA/EU statistical guidelines and regulatory requirements.
Knowledge of related functions: clinical operations, data management, regulatory affairs, and safety.
Strong project management and vendor negotiation skills.
Excellent analytical and communication abilities.
Job Complexity:
Tackles unique and complex issues using independent judgment.
Works on projects involving intangible and multifaceted analysis.
Influences corporate methods and creates formal networks across teams.
Frequently interacts with senior executives and major clients.
Compensation and Benefits:
Base Salary Range: $187,500 – $266,000 (based on region, experience, and internal equity)
Bonus Eligibility: Discretionary annual bonus or sales-based incentive (for field roles)
Equity Participation: Eligible for company stock and long-term incentives
Benefits Include:
401(k) with company match
Medical, dental, and vision insurance
Life and disability insurance
FSAs
15 vacation days (first year)
17 paid holidays (including winter shutdown)
10 sick days annually
Exelixis is proud to be an Equal Opportunity Employer, fostering diversity and inclusion in the workplace. All qualified applicants will receive consideration without regard to race, color, gender, sexual orientation, gender identity, religion, national origin, age, veteran status, disability, or any other protected status.
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