54 data-"https:"-"https:"-"https:"-"https:"-"https:" positions at Center for Drug Evaluation and Research (CDER)

FDA Research Fellowship: Biologic Products and the Regulatory Evaluation of Biosimilars

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 23 hours 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

FDA Modeling and Simulation Fellowships

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 23 hours 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

FDA High-resolution Analytics Fellowship for Oligonucleotide Therapeutics

Center for Drug Evaluation and Research (CDER) | Saint Louis, Missouri | United States | about 23 hours 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

FDA Fellowship - Enhancing Oncology Dose Optimization Through Patient-Reported Outcome Exposure-Response Analysis

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 23 hours 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

FDA Over the Counter Drug Monograph Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

: Conduct literature searches on specific monograph drug active ingredients using regulatory science databases and evaluate scientific evidence supporting safety and effectiveness determinations. Data

FDA Serum Creatinine Elevation Due to Renal Transporter Inhibition

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

project and under the guidance of the mentor, you will contribute with: Collecting comprehensive data on oncology drugs known to inhibit renal transporters (particularly OCT2, MATE1, and MATE2-K), including

FDA Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 23 hours ago

-making regarding appropriate dosing, clinical trial design, and labeling of oncology drugs for patients with obesity. During the appointment you will: Engage in comprehensive data analysis of oncology

FDA Computational Toxicology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 2 days ago

(QSAR) models. The selected participant will learn to harvest and interpret toxicology data, develop and apply QSAR models, and communicate research results to both internal and external stakeholders

FDA Evaluating Consumer Study Regulatory Review Approaches for Applications with Novel Digital Technologies

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 23 hours ago

. Mitigations (rules that may change an incorrect response in a study to a correct response) and participant verbatim information requiring qualitative analysis, complicate consumer study review, making review

FDA Biomarker Qualification Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 23 hours ago

miscategorization of subjects with potential DILI risk during regulatory review.  Through this opportunity, you will cooperate in research and training activities related to computer modeling and statistical analyses