Senior Statistical Programmer

Responsibilities:

• Annotate Case Report Form ) following FDA/CDISC or sponsor guidelines.
• Develop SDTM specifications and generate SDTM datasets using SAS.
• Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
• Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.
• Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
• Create electronic submission package to FDA, e.g., or following FDA guidelines with minimum supervision.
• Proficient in analyze information and develop innovative solutions to programming and data analysis challenges; 
• Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation
• Follow and reinforce regulatory agency requirements during daily job.
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