Clinical Data Science Professional with 12+ years of experience in analysis, design, development, testing, and implementation of Clinical Trial projects within the Pharmaceutical, CRO, and Biotech industries. I possess a deep understanding of life sciences and the drug development process, spanning from protocol design to FDA submissions across all clinical trial phases (I-IV). My expertise includes therapeutic areas such as Infectious Diseases, Virology, HIV, Respiratory, Vaccines, Immunology, and Gastroenterology.I have extensive experience in SAP/OPS preparation, along with a thorough knowledge of clinical trial phases, clinical protocols, CRFs, annotated CRFs, ICH and GCP guidelines, and 21 CFR regulations. I am also well-versed in electronic submissions to the FDA.My technical skills include excellent SAS programming capabilities, particularly in implementing CDISC for special purpose domains, events, findings, interventions, and trial domains. I am adept at implementing ADaM (Analysis Data Model) and generating analysis datasets specific to clinical studies. I have a proven track record in producing and validating Tables, Listings, and Graphs (TLFs) using Base SAS, SAS/Graph, SAS/Macros, and SAS/ODS. Additionally, I have experience with ISS (Integrated Summary of Safety) and ISE (Integrated Summary of Efficacy) for FDA submissions according to the Statistical Analysis Plan (SAP).In the realm of clinical programming, I excel in activities such as eCRF design using EDC systems like Medidata Rave and report creation. I am proficient in developing and testing clinical study EDC databases (Medidata Rave and Inform), including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, and custom functions.My data science experience includes extensive work with machine learning models, including training, validating, and deploying models for predictive analytics and other applications. I am experienced in model selection, feature engineering, and model evaluation techniques to ensure the highest performance and reliability.I am skilled in using SQL, PL/SQL, SAS Programming, R, and Python for data manipulation, analysis, and visualization.Key Skills: SQL, PL/SQL, SAS Programming, R, PythonCertifications: Oracle Certified Associate in SQL and PL/SQL