3 coding-"https:" "https:" "https:" "https:" "https:" "https:" "I.E" "Helmholtz Zentrum Geesthacht" uni jobs at Center for Drug Evaluation and Research (CDER)

FDA Enhancing the Review of Mediation Analyses: Developing a Regulatory Checklist and AI Support Tool

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 30 days ago

—an international consensus guideline that promotes transparency and reproducibility in mediation analyses (JAMA 2021;326(11):1045–1056; https://jamanetwork.com/journals/jama/fullarticle/2784353 )—as the

FDA Evaluating the Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 13 days ago

are at least two PBPK maternal models to predict the PK profile of LAI drug products (i.e., cabotegravir, aripiprazole) in pregnant and lactating people. These PBPK models will help predict drug exposure during

FDA Bayesian Inference for Safety Signal Detection

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 13 days ago

Science (CDS) staff, you will develop comprehensive expertise in Bayesian statistical methods for safety signal detection. Training will include structured learning through selected reading, guided coding