Senior Statistical Programmer / Analyst III

Senior Statistical Programmer / Analyst III

Responsibilities:

• Annotate Case Report Form (acrf.pdf) 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., define.xml or define.pdf 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 inter...