70 machine-learning "https:" "https:" "https:" "https:" "The Open University" positions 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 | 5 days ago

—an international consensus guideline that promotes transparency and reproducibility in mediation analyses (JAMA 2021;326(11):1045–1056; https://jamanetwork.com/journals/jama/fullarticle/2784353 )—as the

FDA Fellowship - Integrated Clinical Trial Database Development for Drug Safety

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 21 hours ago

, training in FDA regulatory processes, and instruction in clinical safety review. You will receive training in advanced statistical methods for safety signal detection, machine learning applications in

FDA Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 21 hours ago

familiar with CDER research areas and develop interest in future careers related to the FDA's public health mission. Support includes access to an FDA-issued computer with required software and weekly mentor

FDA Application of AI for Precision Medicine Fellowship

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

therapeutics and generic drugs. This effort covers more than just medicines. Research Project: This project applies artificial intelligence (AI) and machine learning (ML) to advance precision medicine by

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 21 hours 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 Computational Biology and Pharmacology Fellowship

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

artificial intelligence applications in drug development. You will gain experience researching advanced in silico prediction algorithms, analyzing machine learning approaches for toxicity pattern recognition

FDA Modeling and Simulation Fellowships

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

to increase ANDA review efficiency and quality. Use and development of artificial intelligence (AI), machine learning (ML) and large language models (LLMs) to help promote business intelligence in the Agency

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 | about 21 hours 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 Evaluating Consumer Study Regulatory Review Approaches for Applications with Novel Digital Technologies

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 21 hours ago

science research design and data analysis within a regulatory context. Learning Objectives: There will be structured weekly meetings with the mentor (the deputy division director in DNPD II) and co-mentor

FDA High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 21 hours ago

both the development and regulation of oligonucleotide drugs. Learning Objectives: Under the guidance of the mentor, you will receive instructions on utilizing chromatography, mass spectrometry, and