14 parallel-processing-bioinformatics-"https:" 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 | 11 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 Utilizing Artificial Intelligence to Enhance Pharmacovigilance and Inspection Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

-consuming tasks are replaced by streamlined computerized processing that enhances surveillance for timely detection of new emerging issues for drug and inspection related activities. Under the guidance of a

FDA Product Specific Guidance and Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day 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 Fellowship - Integrated Clinical Trial Database Development for Drug Safety

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 15 hours ago

database from randomized and controlled clinical trials for drugs intended to treat diabetes, overweight, and lipid disorders, enhancing FDA's safety signal detection capabilities. You will collaborate with

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 | 1 day 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 Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day 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 Evaluating Time-Course of Anti-Drug Antibodies for Therapeutic Proteins Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day 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 Fellowship - Assessing Rare Safety Signals in Psychiatric Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 15 hours ago

therapeutics and generic drugs. These efforts cover more than just medicines. Research Project: Safety assessments for medications intended to treat psychiatric conditions present unique challenges in signal

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

miscategorization of subjects with potential DILI risk during regulatory review.  Through this opportunity, you will cooperate in research and training activities related to computer modeling and statistical analyses

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day 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