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

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 21 days 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 Evaluating Time-Course of Anti-Drug Antibodies for Therapeutic Proteins Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 21 days 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 Fellowship - Sex Differences in Efficacy/Safety Outcomes of HIV Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 21 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 CDER Regulatory Science Fellowship

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

science databases.  This data analysis may be performed using various programming languages such as, SAS, R, or Python.  As part of this opportunity, you will be able to engage with a multi-disciplinary

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

Center for Drug Evaluation and Research (CDER) | United States | 21 days ago

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

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 | 21 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 Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 21 days 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 Fellowship - AI to Evaluate Maximum Daily Dose for Topical Drugs

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 21 days ago

prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. Research Project: Maximum daily dose (MDD) refers to the highest amount of active ingredient

FDA CDER Regulatory Science Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 21 days ago

science databases.  This data analysis may be performed using various programming languages such as, SAS, R, or Python.  As part of this opportunity, you will be able to engage with a multi-disciplinary

FDA Risk Assessment of Contaminants for Supply Chain Risks

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 21 days ago

contamination as a risk analysis template, You will contribute to research and map drug products with potential supply chain risks. Learning from and collaborating with a team, you will investigate other