19 parallel-processing-"UCL" Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship in Statistical Methods for New Approach Methodologies (NAMs)

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago

statistical methods for evaluating parallelism of dose-response curves between test and reference standards through simulation studies. Evaluation of multiple statistical approaches — including logistic

FDA NLP Consumer Data Review Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago

language processing (NLP) to automate FDA’s review of these qualitative responses, potentially providing both more accurate and efficient review of consumer data. Learning Objectives: Under the guidance of a mentor

FDA Fellowship in Mechanistic Modeling and Clinical Data Analysis of Emerging Drugs

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 hour ago

a data processing pathway and model validation method that will be used in various areas with particular emphasis on drug polypharmacy. You will also help in analyzing and visualizing data generated

FDA Fellowship - Mechanistic Modeling and Simulation

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 hour ago

products and manufacturing processes. The research will contribute to the development of scientific principles, evaluation strategies, and best practices for the use of computational models and AI-enabled

FDA Fellowship Investigating the Impact of Formulation and Manufacturing Factors on the Injectable Sustained-Release Drug Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago

generic product development of opioid product. The research also includes investigating issues that are related to the manufacturing process of in-situ forming extended-release dose form. Learning

FDA Fellowship: Evaluation of Novel Endpoints and Innovative Statistical Methodology in Oncology Clinical Trials

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago

Prognostic Impact: Standard approaches to handling intercurrent events — such as avoidance of surgery in the perioperative treatment setting, transplant, treatment switching or use of subsequent therapies

FDA Fellowship in Regulatory Science Advancement for Continuous Glucose Monitoring (CGM) Endpoints

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago

participate in the creation, testing, and refining structured prompts using FDA's AI tool to automate routine CGM data cleaning, merging, and processing tasks, assess the impact of these standardized prompts

FDA Fellowship - Applications of Artificial Intelligence, Modeling, and Simulation to Pharmaceutical Manufacturing and Product Characterization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 months ago

of AI-based methods, mechanistic models, and simulation frameworks relevant to pharmaceutical manufacturing processes and product characterization. Areas of focus may include but are not limited

FDA Immunogenicity Risk Assessment Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 2 months ago

activation response, or indirect, by inducing anti-drug antibodies. Product and process impurities can enhance the risks by triggering innate immune receptors that foster the accumulation and activation

FDA Fellowship - Rapid Sterility Testing Innovation: Evaluating ATP-Bioluminescence Technology for Regulatory Science Applications

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 hour ago

. The participant will inoculate relevant biomanufacturing process fluids with bacteria species to determine potential matrix interference and assay limitations. Results from this study will be reported to the cross