80 programming-"https:" "https:" "https:" "BioData" positions at Center for Drug Evaluation and Research (CDER)

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 | 1 day ago

framework for selecting (primary) endpoint strategies and determining the corresponding statistical analysis plan for non-malignant hematologic diseases in confirmatory trials, starting with the use

FDA Pediatric Drug Development Programs for Drug-Device Combination Products Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

for the development of age-appropriate delivery devices. In this project, pediatric drug development programs for drug-device combination products will be systematically reviewed to gain a better understanding of the

FDA Postdoctoral Fellowship / Research Fellowship: 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 | 1 day ago

at key checkpoints—specifically, the study protocol, statistical analysis plan (SAP), and clinical study report (CSR). You will use the AGReMA (A Guideline for Reporting Mediation Analyses) statement

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 | 18 days ago

at key checkpoints—specifically, the study protocol, statistical analysis plan (SAP), and clinical study report (CSR). You will use the AGReMA (A Guideline for Reporting Mediation Analyses) statement

FDA Fellowship - Sex Differences in Efficacy/Safety Outcomes of HIV Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day ago

will: Gain foundation knowledge in antiretroviral drug classes, meta-analysis methodologies, clinical trial data analysis, and R programming. Training in this area will occur through a structured program

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

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 1 day ago

regulatory pathways, R programming for web-based visualization, and R Shiny application development. You will gain experience in creating practical tools for regulatory use, development of programming skills

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 | 1 day 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 Fellowship - Evaluation of Non-Inferiority Margin for Drug Products

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

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 the valid immigration statuses

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 | 1 day 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 In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 1 day ago

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 the valid immigration statuses