Biostatistics Director

SUMMARY / JOB PURPOSE :

Provides leadership within biostatistics function to develop and execute statistical strategy, design and analyses for clinical trials in all phases. 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. Develops and implements biostatistics department policies, standards, practices and work-instructions in coordination with department leader and leaders in other functions. Provides strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success. Represents biostatistics function in interactions with institutional review boards, ethics committees, and health agencies. Manages timelines, deliverables and budgets of contract research organizations.

Essential Duties And Responsibilities :

• Work with department head to develop and implement department standards and practices.
• Direct the statistical design, conduct, and analysis of clinical trials in all phases.
• Review protocols and case report forms for soundness of trial design.
• Review and or author statistical analysis plans for all phases of a trial.
• Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
• Direct the development, validation and summary of integrated safety and efficacy summaries.
• 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.
• Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables and budgets.
• Responsible for all statistical oversight within a therapeutic area.

Supervisory Responsibilities :

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education / Experience :

Experience / The Ideal for Successful Entry into Job :

Knowledge / Skills :

JOB COMPLEXITY :

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $187,500 - $266,000 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.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.