20 parallel-processing-"KTH" Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship in Statistical Methods for New Approach Methodologies (NAMs)

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

statistical methods for evaluating parallelism of dose-response curves between test and reference standards through simulation studies. Evaluation of multiple statistical approaches — including logistic

FDA Fellowship - Inactive Ingredient (IID) Program operated by OB

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago

) serves as an important resource for identifying inactive ingredients (excipients) present in FDA-approved drug products, supporting both drug development and regulatory processes. This opportunity will

FDA NLP Consumer Data Review Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

language processing (NLP) to automate FDA’s review of these qualitative responses, potentially providing both more accurate and efficient review of consumer data. Learning Objectives: Under the guidance of a mentor

FDA Fellowship - Office of Pharmaceutical Quality (OPQ) Initiative - Data Analysis

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

processes, databases, and the regulatory assessment of drug applications. Mentor: The mentor for this opportunity is Nancy Tian ([email protected] ). If you have questions about the nature

FDA Fellowship in Mechanistic Modeling and Clinical Data Analysis of Emerging Drugs

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago

a data processing pathway and model validation method that will be used in various areas with particular emphasis on drug polypharmacy. You will also help in analyzing and visualizing data generated

FDA Fellowship in Regulatory Science Advancement for Continuous Glucose Monitoring (CGM) Endpoints

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

participate in the creation, testing, and refining structured prompts using FDA's AI tool to automate routine CGM data cleaning, merging, and processing tasks, assess the impact of these standardized prompts

FDA Fellowship - Mechanistic Modeling and Simulation

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

products and manufacturing processes. The research will contribute to the development of scientific principles, evaluation strategies, and best practices for the use of computational models and AI-enabled

FDA Fellowship Investigating the Impact of Formulation and Manufacturing Factors on the Injectable Sustained-Release Drug Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

generic product development of opioid product. The research also includes investigating issues that are related to the manufacturing process of in-situ forming extended-release dose form. Learning

FDA Fellowship: Evaluation of Novel Endpoints and Innovative Statistical Methodology in Oncology Clinical Trials

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

Prognostic Impact: Standard approaches to handling intercurrent events — such as avoidance of surgery in the perioperative treatment setting, transplant, treatment switching or use of subsequent therapies

FDA Fellowship in Regulatory Science Advancement for Continuous Glucose Monitoring (CGM) Endpoints

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago

participate in the creation, testing, and refining structured prompts using FDA's AI tool to automate routine CGM data cleaning, merging, and processing tasks, assess the impact of these standardized prompts