28 Design-"https:"-"https:"-"https:" 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 | about 4 hours 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 | 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 Fellowship in Nasal and Pulmonary Drug Delivery and In Vitro Permeability Research

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

will receive training and participate in the design, conduct, optimization, and interpretation of in vitro studies using human-relevant respiratory epithelial models. Experimental activities may include

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 4 hours ago

that reflect meaningful treatment contrasts. Evaluation of Novel Endpoints in Rare Disease Settings: Many rare oncology disease settings have clinical trial design challenges due to a lack of available endpoints

FDA Fellowship in Development and Control of Cell Free Manufacturing Platform Technologies

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

guidelines to experimental design. You will also learn how to communicate research findings effectively, bridging the gap between bench science and regulatory policy. Your training and acquired skill set will

FDA Nonclinical Neural NAMs Fellowship

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

, confocal microscopy, and gene manipulation, with a focus on comparing drug effects across monolayer and three-dimensional organoid systems. You will learn how applied regulatory research is designed at FDA

FDA Fellowship: Food Effect Evaluation for Oncology Drugs

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

to collaborate with FDA scientists and engage in comprehensive research initiatives that identify the factors impacting food effect, summarize the commonly used food effect study design, and investigate

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 4 hours ago

to distinguish and formally model missing data mechanisms as they apply to CGM-specific intermittent and informative missingness patterns, design simulation studies to evaluate and benchmark existing and novel

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

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

automation, and regulatory-standard reporting. Master quantitative risk assessment principles, including the statistical and scientific basis for safety margins, and design simulation studies to evaluate

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 4 hours ago

mentor and other staff scientists while being encouraged to participate in problem solving and study design as each facet of the project advances. You will learn about the purpose and strategy