Sr Director, Biostatistics

About the role

Provides leadership to the biostatistics function and direct management of biostatistics staff in developing statistical strategy, design, and analyses for clinical trials for multiple compounds with a focus on early phase (1/2) trials. Sets direction for statistical support of translational medicine and clinical biomarkers. Understands at a deep level clinical trials principles for early development, translational medicine strategy and clinical biomarker strategy. Applies sound statistical methodology to meet key project objectives related to early development including clinical biomarker and translational medicine objectives.

Responsibilities

• Develops and/or applies statistical theories, methods, and software.
• Promotes and partners in early clinical development program study design, biomarker strategy and translational medicine strategy establishing standards for clinical conduct, and the collection, management and/or reporting of data.
• Recruits, develops, and supervises project statisticians.
• Conceptualizes and implements initiatives for process improvement and or standardization for biostatistics activities and deliverables.
• Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.
• Manages timelines, deliverables, and budgets of contract research organizations.

Requirements

Responsible for all statistical oversight of early development projects. Provide strategic input on Exelixis early development clinical development programs. Provides critical input on translational medicine and clinical biomarker strategy. Develops and applies statistical theories, methods, and software. Promotes and partners in early clinical development program study design, biomarker strategy and translational medicine strategy establishing standards for clinical conduct, and the collection, management and/or reporting of data.

Qualifications

• MS/MA degree in Statistics/Biostatistics or related discipline and a minimum of 13 years of related experience; or, PhD in Statistics/Biostatistics or related discipline and a minimum of 12 years of related experience; or, Equivalent combination of education and relevant experience in oncology.
• Managed clinical trials in the therapeutic area of oncology for at least 5+ years and other therapeutic areas for 10+ years.
• Experience working with and analyzing clinical biomarker and large genetics and omics datasets.
• Experience managing multiple statisticians.
• Has led phase 1 and phase 2 oncology studies.
• Knowledgeable regarding FDA/EMA/ICH guidelines for drug development, new methodology in statistics and statistical/clinical data analyses.
• Knowledge of CDISC standards.
• Ability to work simultaneously on multiple projects and multiple compounds, and to deliver high-quality work according to tight timelines.

Skills

• Strong people management and interpersonal skills.
• Strong communication skills.
• Strong conflict management skills.
• Comprehensive and detailed knowledge of statistical experimental designs, analyses, and clinical trial requirements, particularly pertaining to early development oncology trials.
• Excellent knowledge of FDA/EU/ICH statistical guidelines.
• Functional understanding of other disciplines such as data management, clinical operations, clinical science, regulatory affairs, and drug safety.
• Project management and contract negotiation with outside vendors.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles and to achieve these goals in creative and effective ways.
• Develops technical and/or business solutions to complex problems.
• Applies strong analytical and business communication skills.

Benefits

Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $248,000 - $352,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.