67 web-programmer-developer "https:" "https:" "https:" "https:" "https:" "https:" "University of Kent" positions at Center for Drug Evaluation and Research (CDER)

FDA Enhancing the Review of Mediation Analyses: Developing a Regulatory Checklist and AI Support Tool

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

analyses in clinical trial submissions to the U.S. Food and Drug Administration (FDA). The project focuses on developing a structured framework to guide statistical reviewers in evaluating mediation analyses

FDA Fellowship - Elsa API integration and Development of Advanced User Interface for InfoViP

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 10 hours ago

, pharmacoepidemiology methods development). You will have learning opportunities that include: Understanding of pharmacovigilance data analysis workflows; Full-stack web-based application development; Integration

FDA Clinical Pharmacology / Model Informed Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

the end of the program, you will understand principles of dose selection and optimization across drug development stages and gain insight into FDA decision-making for complex modalities. Skills developed

FDA Developing Novel Technologies for Identification/Characterization of Glycans on Glycoproteins

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 10 hours ago

the guidance of the mentor, you will learn state-of-the-art technologies and develop novel technologies for feasible analysis of glycosylation of therapeutic glycoprotein drugs, including monoclonal antibody

FDA Development of Analytical Methods to Assess Nitrosamine Impurities in Over-the-Counter (OTC) Monograph Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 10 hours ago

). The project is to develop liquid chromatography-mass spectrometry (LC-MS) methods for the analysis of nitrosamine impurities in drug products and apply the developed and validated methods to screen

FDA Fellowship - Development of AI Technologies for Causality Assessment

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 10 hours ago

workflows; GenAI based algorithm and agent development for causality assessment; Web-based tool development for the support of dataset collection; Performance evaluation and validation for the developed AI

FDA Bayesian Statistical Approaches to Address the Unique Challenges of Rare Disease Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

disease drug development within FDA's regulatory framework. You and mentors will research Bayesian dynamic borrowing methods for augmenting small sample sizes through incorporation of historical data

FDA Fellowship - Integrated Clinical Trial Database Development for Drug Safety

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

a multidisciplinary team to develop frameworks for standardizing and combining subject-level data from hundreds of clinical trials, including over 20 completed cardiovascular outcome trials. You will

FDA Fellowship - Development and Validation of AI Prompts to Summarize Industry Submissions

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 10 hours ago

therapeutics and generic drugs. These efforts cover more than just medicines. Research Project: The project involves using FDA’s AI tool ‘Elsa,’ which uses either Claude Sonnet or Gemini models, to develop

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 10 hours ago

therapeutics and generic drugs. These efforts cover more than just medicines. Research Project: The participant will collaborate with statistical and clinical reviewers to research and develop a practical