Sr Director, Biostatistics

SUMMARY/JOB PURPOSE:

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.   Develops and/or applies statistical theories, methods, and software. 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. Takes a leadership role in developing and implementing biostatistics department policies, standards, practices, and work-instructions in coordination with senior leaders in biometrics and other functions.   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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• 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
• Provide vision and direction for the development and implementation of department standards and practices and oversite of process improvement initiatives
• Provide technical oversight of the statistical design, conduct, and analysis of early phase clinical trials.
• Review protocols for soundness of trial design.
• Review statistical analysis plans and case report forms.
• Lead and directly manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, costs, methods, and resourcing.
• Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements and ensure ongoing agreement on project development.
• Contribute to the development of Requests-for-Proposals for evaluation of Contract Research Organizations and other vendors providing services for biostatistics, and programming activities.
• Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables, and budgets.
• Interpret, execute, and recommend modifications to companywide policies and/or divisional programs.  May establish organizational policies in a major segment of the company.
• Build strong relationships both within and outside biostatistics

SUPERVISORY RESPONSIBILITIES:

• Direct management and supervision of biostatisticians.
• Indirectly supervise employees in other functions through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• 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.

Experience/The Ideal for Successful Entry into Job:

• 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.
• Experience interacting directly with FDA and/or EU Authorities preferred.

Knowledge/Skills: