Senior Statistical Programmer I & II

Role Overview: You will be responsible for annotating Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. You will develop SDTM specifications and generate SDTM datasets using SAS. Additionally, you will develop ADaM specifications and generate ADaM datasets using SAS based on the Statistical Analysis Plan. Your role will involve developing Tables, Listings, Graphs, and Patient Profile in support of the Clinical Study Report, Posters, and Manuscripts. Furthermore, you will create electronic submission packages to FDA, such as define.xml or define.pdf, following FDA guidelines with minimum supervision. You will also analyze information and provide innovative solutions to programming and data analysis challenges. Active communication with statisticians for statistical input and analysis interpretation will be a part of your responsibilities. Key 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 the Statistical Analysis Plan - Develop Tables, Listings, Graphs, and Patient Profile in support of the Clinical Study Report, Posters, and 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., define.xml or define.pdf following FDA guidelines with minimum supervision - Analyze information and develop innovative solutions to programming and data analysis challenges - Actively communicate with statisticians for statistical input and analysis interpretation - Follow and reinforce regulatory agency requirements during daily job - Serve as a programming team lead and contribute to department initiatives - Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams - Review draft and final production deliverables for projects to ensure quality and consistency Qualification Required: - Masters / Bachelors degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology, or related scientific disciplines - 8-13 years of experience in Statistical Programming in the Clinical domain,