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Title:Director, Biostatistics
Salary:Open
Experience:5+
Location:CA - San Francisco

Description:
Lead the biostatistics functions and personnel to develop and execute statistical strategy, design, and analyses for clinical trials in all phases that establish the conditions essential for determining dose, safety, and marketability of pharmaceutical and/or biological products.

Responsibilities:
  • 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 program design and in 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 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.
  • Work with department head to develop and implement department standards and practices
  • Direct the statistical design, development, modification and evaluation of clinical trials in all phases
  • Review protocols, analysis plans and case report forms for soundness of trial design.
  • Direct the development, validation and summary of integrated safety and efficacy summaries.
  • Perform analysis, interpret study results, and collaborate with clinical team to produce interim reports, final reports, and publications.
  • 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.

Requirements:
  • Ph.D. or equivalent in Statistics or Biostatistics
    • Must have 5 or more years experience in the application of statistical theory and methods to clinical trials and drug development (i.e. Phase I-IV).
    • 3 or more years experience managing other staff in the pharmaceutical or health care industry

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