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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.
- 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
- 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