48 programming-"https:" "https:" "https:" "I.E" "UCL" "UCL" Fellowship positions at Center for Drug Evaluation and Research (CDER) in United States

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 | 16 days 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 | 16 days 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 | 16 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 Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 16 days ago

significantly (i.e., up to 2-fold) because they can be influenced by prevalent subclinical liver disease in the local population.  Lack of uniform absolute values for ALT upper limit of normal (ULN) can result in

FDA Regulatory Science Research Project Related to Safety of Medications in Pregnancy in the Post Approval Setting

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 16 days ago

(i.e. same study protocol for both regions). Define the characteristics of the study: e.g. study method (pregnancy registry, claims database study, descriptive pregnancy safety study) is the intent

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 16 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 Fellowship - Sex Differences in Efficacy/Safety Outcomes of HIV Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 16 days 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 CDER Regulatory Science Fellowship

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

science databases.  This data analysis may be performed using various programming languages such as, SAS, R, or Python.  As part of this opportunity, you will be able to engage with a multi-disciplinary

FDA Fellowship - Rapid Sterility Testing Innovation: Evaluating ATP-Bioluminescence Technology for Regulatory Science Applications

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

page  of the program website for information about the valid immigration statuses that are acceptable for program participation. This program, administered by ORAU through its contract with the U.S

FDA In Vitro and In Vivo Bioequivalence Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 16 days 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