80 web-programmer-developer "https:" "https:" "https:" "https:" "https:" "Newcastle University" positions at Center for Drug Evaluation and Research (CDER) in United States

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 | about 3 hours ago

mentor, you will collaborate with clinical reviewers and division leadership, contribute to potential policy discussions on trial diversity requirements, develop skills in creating regulatory-relevant data

FDA Bayesian Inference for Safety Signal Detection

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

for low frequency events. You will research and develop Bayesian inference methods for detecting safety signals in rare adverse events. Activities include creating prior distributions for low-frequency

FDA In Vitro and In Vivo Bioequivalence Fellowship

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

-analysis to determine appropriate safety strategies to ensure subject safety; and Innovative Biopharmaceutics Assessment Tools - Developing predictive and quantitative methodologies for bioequivalence and

FDA Product Specific Guidance and Research Fellowship

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

how their research supports guidance development and regulatory decision making as part of the Generic Drug User Fee Amendments (GDUFA) Program. Under the guidance of a mentor, you will be trained

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 | about 3 hours 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 CDER Regulatory Science Fellowship

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

team and may help in designing and developing visualizations and dashboards. Results of the research may inform updates to data considerations for internal regulatory science databases. Additionally, you

FDA Bioequivalence of Complex Generic Products Fellowship

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

under abbreviated new drug applications (ANDAs) and NDAs. The project will identify and develop in vitro, in vivo, or in silico techniques that may be capable of determining how various complexity factors

FDA High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

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

both the development and regulation of oligonucleotide drugs. Learning Objectives: Under the guidance of the mentor, you will receive instructions on utilizing chromatography, mass spectrometry, and

FDA Fellowship - Optimization of Drug-induced Liver Injury Analysis Methods

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

methodologies, statistical analysis of rare adverse events, and understanding of health disparities in clinical research. Learning Objectives: You will develop skills in safety signal detection, learn to identify

FDA Properties of Bayesian Hierarchical Model Estimators of Subgroup Treatment Effects

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

decision-making. This educational and developmental program provides you with training opportunities to continue your education and research while enhancing your professional skills. You will also become