54 data-"https:"-"https:"-"https:"-"https:"-"https:"-"https:"-"https:"-"BioData" positions at Center for Drug Evaluation and Research (CDER) in United States
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago
electrophysiology to assess mechanisms of drug effects on cardiac and neuronal ion channels critical for safety evaluation. Additionally, the research will include advanced statistical modeling for data analysis and
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago
efficacy in children often based on data in adults based on assumptions or evidence of disease and response similarity between adults and children. The critical need to systematically assess extrapolation
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago
collaborate with FDA scientists to compile immunogenicity assessment data from multiple regulatory sources, including Biologics License Applications (BLAs), validation reports, and clinical pharmacology review
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 20 hours ago
intelligence-enabled opioid pharmacovigilance and inspection software application that advances drug safety surveillance by integrating real-world data and regulatory data. The new comprehensive multi-resource
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago
analyzing data within the Center for Drug Evaluation and Research (CDER) drug submission database. The project will help modernize CDER’s data analytics capabilities and support FDA’s mission to protect
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago
disease drug development within FDA's regulatory framework. You and mentors will research Bayesian dynamic borrowing methods for augmenting small sample sizes through incorporation of historical data
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago
patients is challenging. The objective of this project is to develop a pediatric oncology database by collecting data from pediatric study protocols, regulatory marketing applications and FDA review
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago
mathematical ADA model to provide quantitative immunogenicity assessment for therapeutic proteins. This model was constructed using antibody titer data from subjects across 10 clinical trials, with ADA time
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago
are made for nucleotide-based therapeutics—such as antisense oligonucleotides, siRNA, and mRNA—intended for neurological diseases. The you will help investigate how safety margins, nonclinical data
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 20 hours ago
considering all the data, not just subgroup specific data. A BHM assumes exchangeability in treatment effects across subgroups after adjusting for effect modifiers and other relevant covariates. In this project