80 machine-learning-"https:" "https:" "https:" "https:" "https:" "University of St" positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Endpoint Strategy Selection and Statistical Analysis Plan for Non-Malignant Hematologic Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago

case studies and best practices for non-malignant hematologic diseases that generalize to other areas to improve consistency. Learning Objectives: Under the guidance of a mentor, you will learn from

FDA CDER Regulatory Science Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 21 hours ago

will have the opportunity to disseminate research findings to internal and external data stakeholders (e.g. publication) Learning Objectives: Under the guidance of a mentor, you will: Develop useful

FDA Pharmacy Compounding Regulatory Analysis Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 19 days ago

compounding. Learning Objectives: Under the guidance of the mentor, you will gain skills and confidence in making scientific presentations; learn how to collect and compile clinical information; and learn

FDA Characterization of Topical Spray Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 20 hours ago

to support regulatory activities. The participant will also learn to characterize physical characteristics of aerosol spray products using instrumentation such as laser diffraction, high-speed imaging, cascade

FDA Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago

. Overall, this project will support the Agency’s efforts to advance pediatric oncology drug development through enhanced clinical pharmacology evaluation. Learning Objectives: During the appointment, you

FDA Fellowship - AI to Evaluate Maximum Daily Dose for Topical Drugs

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 21 hours ago

the evaluation of MDD of topical drug products. You will initially familiarize with FDA’s IT system and take relevant courses and trainings related to clinical trials. Later, you will learn FDA’s Elsa, a large

FDA Risk Assessment of Contaminants for Supply Chain Risks

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

contamination as a risk analysis template, You will contribute to research and map drug products with potential supply chain risks. Learning from and collaborating with a team, you will investigate other

FDA Fellowship - Optimization of Drug-induced Liver Injury Analysis Methods

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 21 hours ago

methodologies, statistical analysis of rare adverse events, and understanding of health disparities in clinical research. Learning Objectives: You will develop skills in safety signal detection, learn to identify

FDA Studying the Critical Quality Attributes of Multispecific Antibodies/Fusion Proteins (SARITA 4400)

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago

trispecific fusion proteins. Using breast and ovarian cancer cell models, you will help develop bioassays to evaluate and improve the quality, safety, and anti-tumor activity of FDA-regulated products. Learning

FDA Fellowship - Development of AI Technologies for Causality Assessment

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 20 hours ago

or risks from sources other than clinical trials. Learning Objectives: You will join generations of scientists in the field of pharmacoepidemiology, pharmacovigilance, and drug safety through this learning