Job Information
ClinChoice Inc. Senior Statistical Programmer/Analyst I in Fort Washington, Pennsylvania
Work for a contract research organization. The job duties of the position include: Serve as a programming team lead and contribute to department initiative. Develop ADaM data, tables, listings, and figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). Create electronic submission package to FDA, e.g., define.xml or define.pdf, following FDA guidelines with minimum supervision. Analyze information and develop innovative solutions to programming and data analysis challenges. Provide guidance, mentoring, and training for team members and help solve issues from cross- functional teams. 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, and Patient Profile in support of the Clinical Study Report, Posters, and Manuscripts (5%). Actively communicate with statisticians for statistical input and analysis interpretation.
May work from the Fort Washington, PA, office location or may telecommute/work from a home location in the U.S.