Associate Director, Biostatistics
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Review protocols & case report forms for soundness of trial design. Write statistical methodology section of the protocol. Prepare analysis plan and computer programs for inferential analyses. Analyze data, provide statistical sections and input for preparation of clinical trial reports. Take statistical lead in publication support and interaction with external experts. Take statistical lead in drug project related activities including design of clinical development programs; Take statistical lead in support of new drug submission/approval; oversee CRO deliverables for trials contracted out.
Employment Type: Full Time or Contract
Experience: 3 years or more
Full-Time Salary Range: $95,000 to $135,000
Consulting Rate (6-month, renewable): $80 to $110 per hour
Requirements: MS in Statistics with at least 6 years of
pharmaceutical experience or PhD in Statistics with 3 years of pharmaceutical experience for Sr. Principal Biostatistician; PhD in Statistics with at least 6 years of experience for Associate Director. Knowledge of SAS. Strong knowledge of clinical trial methodology. Excellent oral and written communication skills. Strong statistical and data analysis skills. Excellent knowledge of FDA/EU statistical guidelines. Excellent knowledge of drug development process; Excellent project management skills; Direct experience with FDA/EU Authority; Participation in international clinical team(s) as a lead statistician.