67 data-"https:" "https:" "https:" "https:" "https:" "https:" "https:" "Univ" 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 23 hours ago

under realistic data-generating scenarios (endpoint correlation, effect assumptions, alpha requirements), compare study power and other metrics (e.g., probability that endpoints are individually

FDA Development of a Cell-based Potency Assay for Reproductive Hormone Therapies

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 23 hours ago

. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program website for information about

FDA Evaluating Consumer Study Regulatory Review Approaches for Applications with Novel Digital Technologies

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 23 hours ago

. Mitigations (rules that may change an incorrect response in a study to a correct response) and participant verbatim information requiring qualitative analysis, complicate consumer study review, making review

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

Center for Drug Evaluation and Research (CDER) | United States | 12 days ago

macular edema (DME), with potential expansion to other retinal indications, through network meta-analysis and patient matching methodologies applied to historical and recent clinical data. The participant

FDA Fellowship - Development of AI Technologies for Causality Assessment

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 23 hours ago

for causality assessments of individual case safety reports. The research project is supported under 21st Century Cures Act (2016) Section 3022 (Drug Safety) to evaluate real-world evidence data on drug’s use

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 23 hours ago

miscategorization of subjects with potential DILI risk during regulatory review.  Through this opportunity, you will cooperate in research and training activities related to computer modeling and statistical analyses

FDA Research Fellowship: Neurodevelopmental Assessment of Prenatal Analgesic Exposure Using Translational Models

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | about 22 hours ago

of great interest to CDER. The resulting data may impact guidelines over the use of a drug of interest in pregnancy. The National Center for Toxicological Research (NCTR) is currently investigating

FDA Over the Counter (OTC) Drug Product Regulatory Analysis of Antigingivitis/Antiplaque Monograph

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 23 hours ago

methods informs OTC drug monographs and labeling. Scientific writing and data analysis/synthesis: Developing a peer-reviewed manuscript for a regulatory science journal with data tables and visual

FDA Fellowship - In Silico and In Vitro Approaches to Inform Polypharmacy and Patient Effects on Opioid Overdose

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 23 hours ago

and become efficient in using various computing languages, such as R, C, and Python, to develop mechanistic models to simulate human pharmacology and utilize High Performance Computing for 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 | about 23 hours ago

barrier integrity and permeability, and compare in vitro findings with available clinical and pharmacokinetic data to assess model performance. These activities will advance understanding of maternal–infant