67 machine-learning-"https:" "https:" "https:" "https:" "https:" "https:" "University of Waterloo" positions at Center for Drug Evaluation and Research (CDER)

FDA Bayesian Statistical Approaches to Address the Unique Challenges of Rare Disease Drug Development

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

the unique challenges of rare disease drug development. Educational activities will include mentorship from FDA biostatisticians, participation in cross-functional team meetings, and structured learning

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 | 3 days ago

case studies and best practices for non-malignant hematologic diseases that generalize to other areas to improve consistency. Learning Objectives: Under the guidance of a mentor, you will learn from

FDA Computational Toxicology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

(QSAR) models. The selected participant will learn to harvest and interpret toxicology data, develop and apply QSAR models, and communicate research results to both internal and external stakeholders

FDA Risk Assessment of Contaminants for Supply Chain Risks

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

contamination as a risk analysis template, You will contribute to research and map drug products with potential supply chain risks. Learning from and collaborating with a team, you will investigate other

FDA Pharmacy Compounding Regulatory Analysis Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

compounding. Learning Objectives: Under the guidance of the mentor, you will gain skills and confidence in making scientific presentations; learn how to collect and compile clinical information; and learn

FDA Characterization of Topical Spray Drug Products

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 3 days ago

to support regulatory activities. The participant will also learn to characterize physical characteristics of aerosol spray products using instrumentation such as laser diffraction, high-speed imaging, cascade

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 | 3 days ago

trispecific fusion proteins. Using breast and ovarian cancer cell models, you will help develop bioassays to evaluate and improve the quality, safety, and anti-tumor activity of FDA-regulated products. Learning

FDA Review of Pediatric Extrapolation and Dosage Optimization

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

. Overall, this project will support the Agency’s efforts to advance pediatric oncology drug development through enhanced clinical pharmacology evaluation. Learning Objectives: During the appointment, you

FDA Quantitative Systems Pharmacology Modeling for Fetal Cardiac Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 3 days ago

turn this project will advance safety and understanding of potential toxicity of FDA-regulated products in the perinatal population. Learning Objectives: Under the guidance of the mentor, you will gain

FDA Fellowship - Development of AI Technologies for Causality Assessment

Center for Drug Evaluation and Research (CDER) | Jefferson, Arkansas | United States | 1 day ago

or risks from sources other than clinical trials. Learning Objectives: You will join generations of scientists in the field of pharmacoepidemiology, pharmacovigilance, and drug safety through this learning