Provide statistical programming support to clinical trials. Produce statistical analyses, including generating SDTM and analysis datasets. Develop SDTM mapping documents; complete programming and validation of CDISC SDTM and ADaM datasets. Interact with other departments, such as Clinical Operations, Project Management, and Data Management to ensure a high level of client satisfaction through successful execution of projects. Assist in review process of study documents such as the CRF, edit specifications written by Data Management, and Statistical Analysis Plans, as needed. Create the CRT packages for the submission of FDA and PMDA ©