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 packages to FDA, e.g., or following FDA guidelines with no supervision.
• Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges;
• Serve as point of contact (POC) of programming with statisticians for statistical input and analysis interpretation;
• Follow and reinforce regulatory agency requirements during daily job.
• Se...