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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