Statistical Programmer

You will be responsible for annotating Case Report Form (acrf.pdf) in accordance with FDA/CDISC or sponsor guidelines. Your role will involve developing SDTM specifications and generating SDTM datasets using SAS, as well as creating ADaM specifications and generating ADaM datasets based on the Statistical Analysis Plan. Additionally, you will be tasked with developing Tables, Listings, Graphs, and Patient Profiles to support Clinical Study Reports, Posters, and Manuscripts. Your duties will also include developing ADaM data, Tables, Listings, and Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE), as well as creating electronic submission packages for FDA, such as define.xml or define.pdf, following FDA guidelines with minimal supervision. You will be expected to analyze information, provide innovative solutions to programming and data analysis challenges, and communicate effectively with statisticians for statistical input and analysis interpretation. As part of your role, you will need to adhere to regulatory agency requirements on a daily basis, act as a programming team lead, and contribute to department initiatives. Furthermore, you will be responsible for providing guidance, mentoring, and training to team members, as well as assisting in issue resolution for cross-functional teams. You will also review draft and final production deliverables for projects to ensure quality and consistency. To be successful in this position, you should possess a Master's or Bachelor's degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology, or related scientific disciplines. Additionally, you should have 8-13 years of experience in Statistical Programming within the Clinical domain.,