48 mobile-programming-"https:" Fellowship positions at Center for Drug Evaluation and Research (CDER)

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 | 16 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 Pediatric Drug Development Programs for Drug-Device Combination Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 16 days ago

for the development of age-appropriate delivery devices. In this project, pediatric drug development programs for drug-device combination products will be systematically reviewed to gain a better understanding of the

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 | 3 days ago

requirements for sterility and bioburden testing. You will develop expertise in Biosafety Level 1 and Level 2 cell handling, sterility testing, bioburden testing, and novel ATP-bioluminescence technologies

FDA Fellowship - In Silico and In Vitro Approaches to Inform Polypharmacy and Patient Effects on Opioid Overdose

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 16 days ago

the concentration-dependent response of human induced pluripotent stem cell-derived neural new approach methodologies (NAMs) to opioids and their reversal by naloxone. The participant will contribute to expanding

FDA Postdoctoral Fellowship in the Application of Microphysiological Systems to Study the Blood-Milk Barrier

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 16 days ago

, hands-on training in MPS design, operation, and analytical evaluation. Educational activities will include: 1) Cell culture training with human mammary epithelial and endothelial cells within PDMS-based

FDA Fellowship - Clinical Pharmacology Considerations for Novel Therapeutic Modalities

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 16 days ago

addresses critical knowledge gaps in emerging therapeutic modalities, specifically immune cell engagers and radioligand therapies, where limited literature and no clinical pharmacology guidance exists due

FDA Postdoctoral Fellowship / Research Fellowship: 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 | 16 days ago

at key checkpoints—specifically, the study protocol, statistical analysis plan (SAP), and clinical study report (CSR). You will use the AGReMA (A Guideline for Reporting Mediation Analyses) statement

FDA Postdoctoral Fellowship in New Approach Methodologies (NAMs)

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 16 days ago

maintenance, primary human cell culture, and drug permeability testing. You will receive instruction in quantitative analysis using LC-MS/MS, pharmacokinetic data interpretation, and the principles of drug

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 | 16 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 | about 3 hours 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