30 finite-element-analysis positions at Center for Drug Evaluation and Research (CDER)

FDA Pharmacy Compounding Regulatory Analysis Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

the principles of scientific analysis. You will research specific bulk drug substances that are being evaluated by FDA, advancing FDA's development of the Bulk Lists of substances that can be used in human

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 22 hours ago

primarily focus on planktonic bacterial growth. You will help conduct a comprehensive literature analysis of oral microbiome dynamics and biofilm-mediated pathogenesis in the gingivitis disease state and

FDA Regulatory Analysis of Dose-Finding and Optimization Approaches in Targeted Oncology Therapeutics

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 22 hours ago

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located in White Oak, Maryland. The Center for Drug Evaluation and Research...

FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) Office of Immunology and Inflammation (OII), located in Silver...

FDA Over the Counter (OTC) Drug Product Regulatory Analysis of Microbial Risks: Case Study on Ophthalmic Eye Drops

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

*Applications will be reviewed on a rolling-basis. FDA Office and Location: A research opportunity is available at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of New Drugs (OND) located in Silver Spring, Maryland. The Center for Drug...

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 22 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 Evaluating Time-Course of Anti-Drug Antibodies for Therapeutic Proteins Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

-course profiles characterized through a two-component semi-mechanistic model that captured the characteristic double-peak pattern of antibody responses. We also explored relationships between antibody

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

evaluation, active ingredient sameness demonstration, and post marketing safety surveillance. This Division coordinates modeling, simulation, data analysis and data mining, and establishes the scientific

FDA Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 22 hours ago

meetings to monitor progress and provide guidance. Learning Objectives: During the appointment, you will develop expertise in BHMs for clinical trial subgroup analysis while gaining proficiency in

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 22 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