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Spec 3, Statistics & Statistics Programming
Ref No.: 18-15441
Location: Herndon, New Jersey
Candidates with PhD are preferred.
At least three years experience

The contract statistician is responsible for developing and implementing statistical analytic solutions to optimally support clinical trials. The position is responsible for the statistical aspects of clinical trials which include protocol development, statistical analysis plan (SAP) development and execution ensuring statistical reporting deliverables for the study reports (tables, listings and figures) are produced with high quality.

• Develop SAP with statistical analysis and reporting details including specifications for derived variables, mock-up tables, listings and figures.
• Program inferential statistical analyses as well as other statistical outputs as needed.
• Conduct exploratory analyses / graphics to support publications and other purposes.
• Ensure high quality deliverables for study report including the sections of detailed statistical methods.
• When required, prepare accurate, high quality reports of clinical trials for Data Monitoring Committees, registration of devices, publications and others.
• Work with division personnel to ensure delivery of high quality and timely statistical services necessary to achieve business goals
• Review protocols and case report forms to ensure adequate control of design of studies.
• Author statistical section of protocols and provide sample size calculations.
• Comprehensive understanding of regulatory guidance and industry initiatives and trends as they relate to statistical methodology and regulatory submissions.