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Director of Biostatistics

  • Job type: Permanent
  • Location: Phoenix
  • Salary: $190000 - $220000 per annum, Benefits: Comprehensive Bonus Package
  • Job reference: MASL12518506
  • Sector: Biostatistics, EPM Scientific
  • Date posted: 25/01/2018
Director of Biostatistics | FDA Experience | Various therapeutic areas |Management of Direct reports | Clinical trials Phase I-I

A transformative Biotech company is looking to hire a Director of Biostatistics that would support its CNS franchise. The director will play a hands-on role in phase I-IV clinical trials and act as a project lead while supervising a team of biostatisticians.

The Director of Biostatistics Will:
  • Serving as the leader for FDA/EMA meetings and Advisory committee meetings
  • Act as an active member of the protocol development team by providing statistical insight and guidance
  • Contributing to vendor section and management
  • Providing operational statistical expertise for early to late phase clinical trial programs
  • Writing and reviewing SAP as well as statistical protocols and SOP
  • Overseeing biostatistics, programming, and data management teams
  • Serving as the leader for FDA/EMA meetings and Advisory committee meetings
  • Act as an active member of the protocol development team by providing statistical insight and guidance
  • Contributing to vendor section and management
  • Providing operational statistical expertise for early to late phase clinical trial programs
  • Writing and reviewing SAP as well as statistical protocols and SOPs
The ideal candidate will have the following skill set:
  • 10+ years in biostatistics in life sciences preferred.
  • Experience with managing complex statistical data and with analytic statistical software
  • Experiencing with modelling and bootstrapping methods
  • Experience with FDA regulatory submissions
  • Familiarity with CDISC relating to FDA/EMA guidelines
  • 7+ years of experience in managing biostatistics teams
  • Oncology experience strongly preferred
  • Excellent verbal and written skills
  • Masters or Ph.D. in Biostatistics or related field
 

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