Senior Statistical Programmer I & II

You will be responsible for annotating Case Report Form (acrf.pdf) according to FDA/CDISC or sponsor guidelines. Your role will involve developing SDTM specifications and generating SDTM datasets using SAS. Additionally, you will develop ADaM specifications and create ADaM datasets using SAS based on the Statistical Analysis Plan. Furthermore, you will be tasked with developing Tables, Listings, Graphs, and Patient Profile to support the Clinical Study Report, Posters, and Manuscripts. You will also work on developing ADaM data, Tables, Listings, and Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). You will create electronic submission packages for FDA, such as define.xml or define.pdf, following FDA guidelines with minimal supervision. As part of your responsibilities, you will analyze information and devise innovative solutions to programming and data analysis challenges. Effective communication with statisticians for statistical input and analysis interpretation is essential in this role. You will need to adhere to regulatory agency requirements on a daily basis. As a programming team lead, you will also contribute to departmental initiatives and provide guidance, mentoring, and training to team members while assisting in issue resolution within cross-functional teams. To be considered for 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.,