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

FDA Advanced Evaluation of Postmarket Product Quality Reports

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours ago

market report management database and tools. The focus of the project will be to conduct data analysis and research different methodologies to identify and compile clusters and/or trends for potential

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

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 9 hours ago

and optimize drug-induced liver injury (DILI) analysis methods to address poor data quality issues. Training activities will include collating DILI subjects from 2024 approved NDAs/BLAs, analyzing

FDA Application of Quantitative Approaches to Streamline Drug Development and Enhance Patient Care

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 8 hours ago

oncology and inflammatory & immune diseases, and to support risk and safety evaluation, to identify endpoints for Type 1 Diabetes. During the appointment, you will use the clinical trial data under NDA and

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 | about 8 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

FDA Application of AI for Precision Medicine Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours 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

FDA Fellowship - Integrated Clinical Trial Database Development for Drug Safety

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 9 hours 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

FDA Regulatory Analysis of Dose-Finding and Optimization Approaches in Targeted Oncology Therapeutics

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 8 hours ago

analyze the impact of these changes on regulatory decision-making. During the project, you will help: Collect comprehensive data on dosage optimization strategies from recently approved oncology New Drug

FDA Review of Pediatric Extrapolation and Dosage Optimization

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 8 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

FDA Evaluating Time-Course of Anti-Drug Antibodies for Therapeutic Proteins Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 8 hours 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

FDA Clinical Pharmacology / Model Informed Drug Development

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 8 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