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:

• 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.
• Has 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.

JOB COMPLEXITY:

• Works on significant and unique issues where analysis scenarios require an evaluation of intangibles.
• Works on complex issues where analysis scenarios require an in-depth knowledge of the company.
• Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.
• Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.
• Ensures budgets and schedules meet corporate requirements.
• Creates formal networks involving coordination among groups.

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