34 computer-science-quantum "https:" "https:" "https:" "https:" "https:" "University of Waterloo" uni jobs at Center for Drug Evaluation and Research (CDER)

FDA 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 | 21 days ago

therapeutics and generic drugs. This effort covers more than just medicines. Research Project: The ORISE Fellow will be a part of a regulatory science initiative aimed at enhancing the review of mediation

FDA Opportunity - Web-based Visualization Tool for NDA/BLA Submission Info

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

applicable to data science careers, and understanding of FDA's information management needs. You will acquire knowledge of regulatory submission processes, MedDRA dictionary applications, CDISC format and

FDA Application of Quantitative Approaches to Streamline Drug Development and Enhance Patient Care

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

and streamline clinical development program, contributing to precision medicine. Learning Objectives: The project provides training opportunities to understand quantitative approaches that can be

FDA Artificial Intelligence and Open-Source Data for Advanced Quality Surveillance

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

leveraging Artificial Intelligence (AI) usage in open-source. This project aims to develop innovative assessment capabilities using techniques such as prompt engineering, data extraction, NLP, time series

FDA Studying the Critical Quality Attributes of Multispecific Antibodies/Fusion Proteins (SARITA 4400)

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

participation. This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency

FDA Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

decision-making. This educational and developmental program provides you with training opportunities to continue your education and research while enhancing your professional skills. You will also become

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 | 4 days ago

. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program website for information about

FDA Bayesian Inference for Safety Signal Detection

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

Science (CDS) staff, you will develop comprehensive expertise in Bayesian statistical methods for safety signal detection. Training will include structured learning through selected reading, guided coding

FDA Development of a Cell-based Potency Assay for Reproductive Hormone Therapies

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

. Presenting the results in scientific forums like FDA ORISE seminar series, CDER science day and FDA science forum. Mentor: The mentor for this opportunity is Mohanraj Manangeeswaran (mohanraj.manangeeswaran

FDA Clinical Pharmacology / Model Informed Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 4 days ago

. Acting collaboratively with Clinical Pharmacology, OND Neurology, and the MIDD program, you help will identify trends and gaps in regulatory practices and synthesize findings into a regulatory science