Clinical Data Scientist
Current1. Collaborate with clinical reviewers in the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) to conduct safety data analyses for new drug applications (NDAs) and biologics license applications (BLAs). 2. Provide expert analysis of safety data collected during clinical trials, including adverse events, laboratory abnormalities, and serious safety issues applying a range of statistical tools and coding techniques to analyze the data, identify trends and patterns, and provide insights to the clinical teams. 3. Ensure that the safety data analysis reports presented are accurate, reliable, and compliant with regulatory standards.