27 data-"https:"-"https:"-"https:"-"https:"-"https:"-"https:"-"Simons-Foundation" Fellowship positions at Center for Drug Evaluation and Research (CDER)
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour 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 1 hour 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 1 hour ago
a multidisciplinary team to develop frameworks for standardizing and combining subject-level data from hundreds of clinical trials, including over 20 completed cardiovascular outcome trials. You will
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago
Office of New Drugs (OND) are creating new and updating existing toxicity databases based on available nonclinical animal data (and available clinical data where applicable) that could be used in
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Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 1 hour ago
. Additionally, you will participate in data evaluation and documentation, collaborating with their mentor on publications, presentations, or reports to learn effective communication of regulatory science to both
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago
or limited multivariate analysis. However, the increasing dimensionality and complexity of analytical data demand AI/ML-based frameworks capable of learning nonlinear, high-dimensional relationships between
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago
evaluation, active ingredient sameness demonstration, and post marketing safety surveillance. This Division coordinates modeling, simulation, data analysis and data mining, and establishes the scientific
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 hour ago
of novel PRO-based ER analyses of tolerability associated drug exposure related adverse events to inform standard ER analyses for safety and provide complementary tolerability data to improve dosage
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Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 1 hour ago
-market surveillance systems suffer from underreporting bias, confounding by indication, and unclear temporal relationships. Meta-analyses based on pooled study-level or subject-level clinical data play a
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Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 1 hour ago
: Conduct literature searches on specific monograph drug active ingredients using regulatory science databases and evaluate scientific evidence supporting safety and effectiveness determinations. Data