23 days old

Associate Director, Biostatistics

Greenwich Biosciences, Inc.
Richmond, VA 23219
  • Job Code
    R0001513
We are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results.

Job Purpose:

The Associate Director, Biostatistics is a member of the clinical sciences team and is responsible for statistical and strategic input to clinical programmes, regulatory filings and interactions, and clinical studies.

The Associate Director, Biostatistics must ensure that activities and processes performed are conducted according to company requirements. This position works closely with other team members and functions.

Responsibilities:

  • Act as representative statistician on clinical programmes and regulatory filings and interactions working closely with senior leadership team to provide key strategic input on study designs and programme strategies.
  • Management of statistical activities and resourcing within a clinical programme.
  • Management of statistical resources required to support clinical programme.
  • Attend meetings with regulatory agencies and respond to regulatory questions regarding submissions and study designs.
  • Work closely with Head of Biometrics providing detailed updates regarding programme status.
  • Work collaboratively with senior leadership.
  • Solve complex statistical issues.
  • Provide expert input and support to statisticians within Biometrics.
  • Act as a deputy for the Head of Biometrics.
  • Can sign on behalf of the Head of Biometrics.

Required Experience:

  • Masters degree in Statistics.
  • Experience with complex statistical techniques.
  • Extensive management/leadership experience.
  • Extensive experience with regulatory interactions and submissions to regulatory agencies
  • At least 12 years. of relevant experience.
  • Expert knowledge of applicable regulatory requirements and guidelines, e.g. ICH Guidelines.
  • Extensive knowledge of statistics and relevant statistical topics and current statistical thinking within the industry.
  • Proficient in the use of computers and especially the SAS system.
  • Able to work in a fast-paced, team-oriented environment.
  • Possess excellent interpersonal and communication skills (written and verbal).
  • Strong attention to detail with a view to bringing studies to a quality conclusion.
  • Flexible, positive, creative thinker, good communicator.
  • Able to work without close supervision.
  • Well-developed time management skills.

Preferred:

  • PhD in Statistics.
  • Bayesian and adaptive design experience.
  • At least 14 years of relevant experience.

Join Us!





Posted: 2020-03-14 Expires: 2020-04-12
Sponsored by:
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Associate Director, Biostatistics

Greenwich Biosciences, Inc.
Richmond, VA 23219

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