20 design-"https:"-"https:"-"https:" Fellowship 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 4 hours ago

framework for selecting (primary) endpoint strategies and determining the corresponding statistical analysis plan for non-malignant hematologic diseases in confirmatory trials, starting with the use

FDA Bioequivalence of Complex Generic Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

device components that may themselves have degrees of complexity in design. In addition, the participant will gain knowledge in collaborating with cross-disciplinary teams to develop novel in vitro, in

FDA Clinical Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

methodology, and translational research design. The participant will develop competencies in good clinical practice (GCP) standards, clinical trial ethics, protocol development, pharmacokinetic data analysis

FDA CDER Regulatory Science Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

team and may help in designing and developing visualizations and dashboards. Results of the research may inform updates to data considerations for internal regulatory science databases. Additionally, you

FDA Postdoctoral Fellowship in the Application of Microphysiological Systems to Study the Blood-Milk Barrier

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

of scientists to evaluate, refine, and validate an innovative MPS platform designed to predict how therapeutic compounds cross the mammary epithelium. The participant will actively conduct experiments, analyze

FDA Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 28 days ago

created new challenges for non-inferiority trial design, as placebo-controlled studies are often no longer ethical and patient populations have become more heterogeneous with varying treatment histories

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

of liver injury cases using clinical trial data. Learning Objectives: Under the guidance of a mentor, You will learn about regulatory science, clinical trial design, and safety analysis. You will collaborate

FDA Postdoctoral Fellowship - Clinical Pharmacology and Immunogenicity Data Assessment

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

analytical tools Learning research database design principles and data management best practices Contributing to development of evidence-based recommendations for regulatory policy enhancement Participating in

FDA Large Language Models (LLM) for Case Definition Classification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

provide feedback on the user experience. This objective will help you understand the importance of human-centered design and how to provide constructive feedback for software development. Support the

FDA In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

vivo, and/or in silico study designs for establishing bioequivalence with these products. Mentor: The mentor for this opportunity is Dongmei Lu (Dongmei.Lu@fda.hhs.gov ). If you have questions about the