Sampath Madanu

Background

About Sampath Madanu

Strong SAS programming experience with extensive knowledge involving all phases (I-IV) of clinical trials for NDA (New Drug Application), NDS (New Drug Submission) and MAA (Marketing Authorisation Application) filing. • Have supported Central Nervous System, Cardivascular and Respiratory therapeutic areas. • Experience in developing & Validating CDISC compliant SDTM datasets from raw data and Analysis data sets - ADaM format from SDTM datasets. • Good Knowledge of CDISC analysis data model (ADaM) and Study Data Tabulation Model (SDTM). • Knowledge of eSubmission processes and define.xml. • Involved in preparing required documents for FDA submission such as ISS, ISE. • Strong knowledge and experience of SAS programming language and experience of using SAS on both Windows and UNIX platforms. • Experience in the preparation of tables, listings and graphs using Base SAS, SAS MACRO and SAS SQL. • Extensive programming ability including programming safety, efficacy to generate tables, listings and graphs. • Experience in Ad-hoc programming for clinical and data management departments. • Strong experience of safety and efficacy reporting. Understanding of clinical data life cycle from data collection to submission. • Good working knowledge of ICH, GCP and FDA regulations and guidelines. • Excellent analytical and problem-solving skills. • Ability to work efficiently on multiple projects. • Ability to work under stress and meet deadlines. • Strong ethical conduct and ability to work with confidential and highly sensitive information. • Strong communication that works well both independently and in team environment. • Highly motivated individual with excellent organizational and interpersonal skills and possess strong ability to quickly adapt to new applications and platforms.