14 multiple-sequence-alignment Fellowship positions at Center for Drug Evaluation and Research (CDER)

FDA Fellowship - Consistent Approach to Maximum Daily Dose Determination

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

to systematically collect and analyze MDD determinations made within the past five years across multiple offices and divisions. Learn to assess alignment and discrepancies between historical MDD determinations, other

FDA Fellowship - Endpoint Strategy Selection and Statistical Analysis Plan for Non-Malignant Hematologic Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 22 hours ago

analyses from recent submissions/literature with emphasis on clinical interpretability, multiplicity control, estimands, and alignment with common regulatory expectations. Analyze operating characteristics

FDA Statistical Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

, noninferiority trials, multiple endpoints, adaptive designs, Bayesian design and analysis methods, estimands, meta-analyses, benefit-risk analyses, subgroup analyses, biosimilars, patient experience data

FDA Fellowship in Regulatory Science Advancement for Continuous Glucose Monitoring (CGM) Endpoints

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

of CGM-derived metrics (e.g., Time in Range (TIR)) relative to hemoglobin A1c (A1C) across multiple clinical trials, calculating and interpreting trial-level correlations across diverse study populations

FDA Computational Biology and Pharmacology Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

nonclinical data (such as chemical structures, sequences, and in vitro functional assays for specific drugs) into safety endpoints (such as cardiotoxicity, immunogenicity, etc.) Learning Objectives: As a

FDA Fellowship in Regulatory Science Advancement for Continuous Glucose Monitoring (CGM) Endpoints

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

of CGM-derived metrics (e.g., Time in Range (TIR)) relative to hemoglobin A1c (A1C) across multiple clinical trials, calculating and interpreting trial-level correlations across diverse study populations

FDA Fellowship in Statistical Methods for New Approach Methodologies (NAMs)

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

statistical methods for evaluating parallelism of dose-response curves between test and reference standards through simulation studies. Evaluation of multiple statistical approaches — including logistic

FDA Global Generic Drug Regulatory Research Fellow

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 22 hours ago

regulatory science by engaging with regulatory scientists and policy experts from multiple national agencies, and will strengthen interdisciplinary competencies in areas such as analytical chemistry

FDA Fellowship - Over the Counter (OTC) Drug Product Regulatory Analysis of Microbial Risks: Case Study on Ophthalmic Eye Drops

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | 4 days ago

label changes to mitigate risks of serious adverse events associated with use of OTC monograph drug products.  This research project is aligned with two critical FDA Focus Areas of Regulatory Research

FDA Fellowship - Rapid Sterility Testing Innovation: Evaluating ATP-Bioluminescence Technology for Regulatory Science Applications

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 22 hours ago

technology, which has been identified as a rapid microbial method that aligns with current pharmaceutical industry trends, to better support submissions utilizing this approach. Researching collaboratively