52 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 | 7 days 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 Fellowship - Optimization of Drug-induced Liver Injury Analysis Methods

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 7 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 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 | 7 days 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 Pharmacy Compounding Regulatory Analysis Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 27 days 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 | 7 days 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 Research Opportunity - Analysis of Patient Diversity and Ineligibility Rates in Cancer Pivotal Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 7 days ago

will receive mentored training in clinical trial design and regulatory submission processes, demographic analysis methodologies, statistical analysis of enrollment patterns, data visualization techniques

FDA Pediatric Extrapolation: Analysis Using FDA Clinical Trial Data

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 7 days 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 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 | 7 days 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 Fellowship - Enhancing Oncology Dose Optimization Through Patient-Reported Outcome Exposure-Response Analysis

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 7 days ago

that traditional clinical assessments may miss. Our published proof-of-concept study demonstrated that PRO-CTCAE-derived ER analysis may offer enhanced sensitivity, and to complement standard ER analysis, by

FDA Biomarker Analysis: Addressing the Gap Between Patient Enrollment Applications and Pharmacodynamic Effect Evaluation

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 7 days ago

to be adjusted accordingly to adequately fit for supporting the updated role. This research is to identify the bioanalysis gap. In this bioanalysis gap analysis. The participant will be involved in