3/22/18- Sr. Biostatistician

3/22/18- Sr. Biostatistician

3/22/18- Sr. Biostatistician

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Accentuate Staffing is currently recruiting for a Sr. Biostatistician to join an established company in the Durham area.  This is a direct hire opportunity.

Responsibilities: 

  • Leading all biostatistics activities related to clinical trials as responsible project statistician
  • Development and review of statistical sections of protocols, including sample size calculations
  • Development of statistical analysis plans
  • Development and documentation of analysis database structures (i.e. SAS analysis data set structures)
  • Development of SAS program requirements and specifications
  • SAS programming and program validation
  • Participation in bid defense meetings
  • Participation in kick-off meetings
  • Communication line for project teams, customers, and vendors for statistical questions.
  • Conduct of project-specific training of statisticians and SAS programmers
  • Coaching and training of statisticians (non-project-related)
  • Preparation and delivery of presentations at investigators’ meetings
  • Preparation for and attendance at internal and third-party study audits pertinent to Statistics
  • Preparation of the answers to the internal/external audits findings/recommendations, and follow-up on and resolution of audit findings
  • Participation in the development of guidelines, procedures and other Quality Systems Documents (QSDs) pertinent to activities of the Biostatistics department

Requirements:

  • MSc in Statistics or equivalent
  • At least 5 years of industry experience in clinical research
  • At least 5 years of industry experience in biostatistics
  • At least 5 years of experience in SAS programming  preferred