Biostatistical support includes performing biostatistical support or providing statistical oversight activities, but is not limited to the following: Develop a Data Management Plan (Deliverable 17), which is a comprehensive document developed to describe all data management activities and their processes and implementation during pre-study conduct, study conduct, and study closure and that reflect Good Data Management Practices based on Good Clinical Data Management Practices (GCDMP), Good Clinical Practices, and ICH guidelines. Develop statistical programming specifications (clinical data) and other statistical programs used to produce the tables, listings, and figures for studies, all versions used for the Data Monitoring Committee, safety surveillance plans, FDA annual report, interim analyses (if applicable), and any ad hoc analyses.