9 parallel-processing Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Statistical Methods for Three-Arm Clinical Trials with Multiple Testing Procedure

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 3 days ago

group. The conventional Dunnett’s type I error rate adjustment proposed in 1955 is for superiority tests with normally distributed data. There are statistical concerns about generalizing the procedure

FDA Product Specific Guidance and Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

research, CDER approved drug products, CDER published guidance including product-specific guidance (PSG), as well as the refinement of processes and infrastructure to analyze and track how research outcomes

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 4 hours ago

the potential to streamline immunogenicity testing by consolidating the multi-tiered process into a single, more efficient method. While the signal-to-noise ratio approach demonstrates clear advantages

FDA Developmental Safety Fellowship

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

review process. Learning Objectives: Under the guidance of the mentor(s),you will develop the following skills during the fellowship; (1) data collection and analysis, (2) clinical pharmacology and

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 | about 4 hours ago

. The goal of these quantitative systems pharmacology models is to define a data processing pathway and model validation method that will be used in various areas with particular emphasis on drug polypharmacy

FDA Large Language Models (LLM) for Case Definition Classification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 4 hours ago

models (LLMs) to enhance case definition processes by developing a prototype that demonstrates the capability of LLMs to accurately categorize and classify case definitions. The selected fellow will

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 | about 5 hours 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 Pediatric Drug Development Programs for Drug-Device Combination Products Fellowship

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

meetings and project meetings, to better understand pediatric drug development and clinical pharmacology concepts. The fellow will be able to observe, but not participate in, the regulatory review process

FDA Computational Biology and Pharmacology Fellowship

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

, and FDA's drug evaluation processes. Additionally, you will develop competencies in data curation and analysis, understand validation criteria for alternative testing methods, and acquire knowledge