82 assistant-professor-computer-"https:"-"https:"-"https:"-"https:" positions at Center for Drug Evaluation and Research (CDER)

FDA Drug Product Quality Assessment

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 11 days ago

standardized test method for assessing benzene content, which will help in making informed regulatory decisions. Results from these studies will be used to evaluate current industry guidance limits and help

FDA High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 11 days ago

activities will entail executing experimental designs, conducting laboratory analyses to help develop analytical methods comprehensively, and gaining insight into drug development and product quality control

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 11 days ago

safety context. Contribute to the usability testing of the AI-assisted review tool: you will interact with the prototype's user interface to perform assigned tasks, document any issues or challenges, and

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 | 11 days ago

well as Bayesian borrowing can help address sample size and ethical concerns for rare diseases. Collaboration between the statistician at DB9 and the clinical team at the Division of non-malignant hematology to map

FDA Dosage Optimization of Antibody-Drug Conjugates

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 11 days ago

or late-stage antibody-drug conjugates (ADCs) in the premarket space to aid selection of safe and appropriate dosages of ADCs. The specific aims are to improve our understanding of the current landscape

FDA Risk Assessment of Contaminants for Supply Chain Risks

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 11 days ago

Q9), assessment of volume of excipients used (exposure analysis), and analysis of historical product quality defect trends. Integrating these data, you will help assess potential risks due

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 11 days ago

methods for the generic drug research program and conducts regulatory science and research activities based on quantitative approaches. Some of the responsibilities residing in DQMM include providing

FDA Regulatory Analysis of Dose-Finding and Optimization Approaches in Targeted Oncology Therapeutics

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 11 days ago

analyze the impact of these changes on regulatory decision-making. During the project, you will help: Collect comprehensive data on dosage optimization strategies from recently approved oncology New Drug

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 11 days 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 Application of AI for Precision Medicine Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 11 days ago

analyzing data within the Center for Drug Evaluation and Research (CDER) drug submission database. The project will help modernize CDER’s data analytics capabilities and support FDA’s mission to protect