SUMMARY/JOB PURPOSE:

Leads the biostatistics function in developing statistical strategy, design, and analyses for conducting clinical trials in all phases for multiple compounds. Understands at a deep level clinical trials principles and norms. Applies sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements. Develops and/or applies statistical theories, methods, and software. Partners in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or reporting of data. Recruits, develops, and supervises project statisticians. Develops and implements biostatistics department policies, standards, practices, and work-instructions in coordination with senior department leader and leaders in other functions. Leads initiatives for process improvement and or standardizations 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:

• Provide vision and direction for the development and implementation of department standards and practices.
• Provide oversite of standardization and/or process improvement initiatives
• Provide strategic input on Exelixis clinical development programs
• Provide technical oversight of the statistical design, conduct, and analysis of clinical trials in all phases.
• Review protocols and case report forms for soundness of trial design.
• Review statistical analysis plans for all phases of a trial.
• Direct analysis, interpret study results, and collaborate with study team to deliver interim reports, final reports, safety updates and publications.
• Guide the successful completion of major programs, projects and/or functions by identifying and implementing appropriate techniques and evaluation criteria.
• Lead or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing.
• Management and statistical analysis of data obtained from Phase I - IV clinical studies in support of NDAs.
• Interact with FDA or EU Authority staff to ensure clinical studies meet regulatory requirements.
• Attend meetings with FDA or EU Authority to ensure ongoing agreement on project development.
• Contribute to the development of Requests-for-Proposals for evaluation of Contract Research Organizations for biostatistics, programming, and data management activities.
• Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables, and budgets.
• Responsible for all statistical oversight within the biostatistics function.
• 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:

• Supervise 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 16 years of related experience; or,
• PhD in Statistics/Biostatistics or related discipline and a minimum of 15 years of related experience; or,
• Equivalent combination of education and relevant experience in oncology.
• May require certification in assigned area.

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.
• Supervision of multiple statisticians required.
• Has led phase 1-4 (preferably phase 3) oncology studies.
• Knowledgeable regarding FDA/EMA/ICH guidelines for drug development, new methodology in statistics and statistical/clinical data analyses.
• In-depth knowledge of CDISC standards.
• Ability to work simultaneously on multiple projects and multiple compounds, and to deliver high-quality work according to tight timelines.
• Direct experience with FDA/EU Authority 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 oncology trials.
• Developed/reviewed SDTM/ADaM specifications.
• Excellent knowledge of FDA/EU/ICH statistical guidelines.
• Must have experience in state-of-the-art data organization and statistical analyses using statistical software such as SAS, EAST, nQuery, Cytel Studio.
• Has understanding of other disciplines such as data management, clinical operation, 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. Regularly interacts with executives and/or major customers.

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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 $271,000 - $385,000 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.

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.