18 parallel-processing-bioinformatics "https:" uni jobs at Center for Drug Evaluation and Research (CDER)

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 | about 1 month ago

—an international consensus guideline that promotes transparency and reproducibility in mediation analyses (JAMA 2021;326(11):1045–1056; https://jamanetwork.com/journals/jama/fullarticle/2784353 )—as the

FDA Advanced Evaluation of Postmarket Product Quality Reports

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 15 days ago

detection.  Through utilizing appropriate platforms and applying modern statistical approaches, such as data mining, natural language processing and deep learning, complex data and large data can be studied

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

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 15 days ago

information to enable real-time summarization and visualization of submission data for FDA reviewers. Learning Objectives: You will receive comprehensive training in eCTD submission processes, NDA/BLA

FDA Determination of Qualification Limits for Peptide-related Impurities of Follow-on Products to Inform Guidance

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 15 days ago

clinical trials when bioequivalence and qualitative comparability to the reference product are demonstrated. However, differences in product quality attributes (including sequence variants and process

FDA Drug Product Quality Assessment

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | 15 days ago

for industry guidance, and the quality assessment of drug products for benzene contamination. You will conduct data interpretation and evaluation, gain regulatory process knowledge, conduct experiments, and

FDA Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 15 days ago

drug marketing applications received, summarize dosage optimization approaches used by the sponsors during pediatric drug development process, and summarize approaches used by the sponsors when

Comparing Neonatal Adverse Drug Events from the Literature with FDA Labels

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 15 days ago

public health mission in order to have a future of highly trained regulatory scientists in clinical pharmacology. Students and fellows can observe, but not participate in, the regulatory review process

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 | 15 days ago

will receive mentored training in clinical trial design and regulatory submission processes, demographic analysis methodologies, statistical analysis of enrollment patterns, data visualization techniques

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 | 15 days ago

experiences in regulatory decision-making processes. You will also engage in professional development seminars on scientific writing for regulatory audiences and presentation skills for technical and policy

FDA Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 15 days ago

designs in various patient populations and understand the regulatory implications of dosing recommendations. Understanding of FDA's drug review process, particularly regarding clinical pharmacology