67 data-"https:" "https:" "https:" "https:" "https:" "https:" "https:" "Univ" "Univ" positions at Center for Drug Evaluation and Research (CDER)
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day 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
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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
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day 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
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day 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
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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
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day 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
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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
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day 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
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day 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
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day 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