81 parallel-computing-numerical-methods positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Optimization of Drug-induced Liver Injury Analysis Methods

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 5 days ago

and optimize drug-induced liver injury (DILI) analysis methods to address poor data quality issues. Training activities will include collating DILI subjects from 2024 approved NDAs/BLAs, analyzing

FDA Development of Analytical Methods to Assess Nitrosamine Impurities in Over-the-Counter (OTC) Monograph Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 5 days ago

). The project is to develop liquid chromatography-mass spectrometry (LC-MS) methods for the analysis of nitrosamine impurities in drug products and apply the developed and validated methods to screen

FDA Fellowship - Statistical Methods for Three-Arm Clinical Trials with Multiple Testing Procedure

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 month ago

statistical simulation and method validation techniques. This is an educational and developmental program in mathematics and statistics, including biometrics and biostatistics, in which you will receive related

FDA Computational Toxicology fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 5 days ago

of funds. Level of Participation: The appointment is full time. Citizenship Requirements: This opportunity is available to U.S. citizens and Lawful Permanent Residents (LPR) only. This program, administered

FDA Computational Toxicology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 5 days ago

. Learning Objectives: Under the guidance of a mentor, the participant will learn about the development of computational models for regulatory use. Research and training activities may include: Learning

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 5 days ago

validation of human-based in vitro and computational methods submitted to FDA for regulatory use. The developed models will be used to predict various toxicity endpoints and drug exposure to help provide

FDA Bayesian Inference for Safety Signal Detection

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 5 days ago

or adverse events in rare disease populations due to limited data and low event frequencies. Frequentist methods often lack sufficient power to detect safety signals in these scenarios. Bayesian methods offer

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 1 hour ago

technology, which has been identified as a rapid microbial method that aligns with current pharmaceutical industry trends, to better support submissions utilizing this approach. Researching collaboratively

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 | 5 days ago

will: Gain foundation knowledge in antiretroviral drug classes, meta-analysis methodologies, clinical trial data analysis, and R programming. Training in this area will occur through a structured program

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

Center for Drug Evaluation and Research (CDER) | United States | 5 days ago

ophthalmology, focusing on wAMD and DME indications. You will collaborate with experienced FDA statisticians to learn advanced statistical methods including network meta-analysis techniques, patient matching