24 design-"https:"-"https:"-"https:"-"Newcastle-University" Fellowship positions at Center for Drug Evaluation and Research (CDER)

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 | 2 days ago

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available within the Food and Drug Administration (FDA) in The Center for Drug Evaluation and Research (CDER), located at White Oak, Maryland. The 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 | 15 days 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 Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

Center for Drug Evaluation and Research (CDER) | United States | 15 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 CDER Regulatory Science Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 6 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 Fellowship - Sex Differences in Efficacy/Safety Outcomes of HIV Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 15 days ago

with twice-weekly mentoring sessions. Learn clinical trial design and analysis, statistical methods for meta-analyses, and gain insights into biological sex impacts on drug efficacy and safety. You will

FDA Bioequivalence of Complex Generic Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 15 days 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 | 15 days 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 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 | 15 days 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 | about 2 months 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 CDER Regulatory Science Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 15 days 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