Biostatistician/Senior Principal Biostatistician
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Job Description: Review protocols & case report forms for soundness of trial design. Write statistical methodology section of the protocol. Prepare analysis plan and programming specifications. Prepare programming for and perform inferential analyses. Write the statistical section of the clinical trial report and review the clinical trial report. Support and participate in drug project related activities including preparation of global submissions. Oversee CRO deliverables for trials contracted out.
Employment Type: Full Time or Contract
Experience: 3 years or more
Education: Masters Degree
Full-Time Salary Range: $80,000 to $110,000
Consulting Rate (6-month, renewable): $65 to $95 per hour
Requirements: MS in Statistics with at least 3 years of pharmaceutical experience or PhD in Statistics with limited experience for senior Biostatistician; MS in Statistics with at least 6 years of pharmaceutical experience or PhD in Statistics with at least 3 years of pharmaceutical experience for Sr. Principal Biostatistician.
Strong statistical and data analysis skills; knowledge of clinical trial methodology. Solid ability in protocol development, analysis planning, and support for clinical trial reports/publications. Good oral and written communication skills. Knowledge of FDA/ICH guidelines. Knowledge of drug development process. Good knowledge of the SAS computer package.
For Sr. Principal Biostatistician: good project management skills and experience in supporting clinical development and/or NDA submissions.