70 data-"https:" "https:" "https:" "https:" "https:" "https:" "https:" "Univ" positions at Center for Drug Evaluation and Research (CDER) in United States

FDA Clinical Pharmacology of Novel Modality Biological Products

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 11 hours ago

, data analysis, and regulatory submission evaluations to identify knowledge gaps and establish best practices for assessment. You will analyze clinical trial datasets to characterize dose-response

FDA Fellowship - Clinical Pharmacology Considerations for Novel Therapeutic Modalities

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 11 hours ago

competencies in research methodology, data analysis, scientific presentation, and manuscript writing skills that support career advancement in regulatory science, pharmaceutical development, or academic research

FDA Biomarker Analysis: Addressing the Gap Between Patient Enrollment Applications and Pharmacodynamic Effect Evaluation

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 11 hours ago

to develop strong critical thinking, improve skills in information extraction and summarization, and scientific communication. Mentor: The mentors for this opportunity are Xiulian Du (Xiulian.Du@fda.hhs.gov

FDA Research Opportunity - Dose Selection of Products for Inflammatory Bowel Disease

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 11 hours ago

dose selection based on adult data and patient-specific factors. Specifically, the fellow will: Survey clinical development programs for IBD products, focusing on dose-selection strategies for adults and

FDA Development of Cell-based Reporter Assays for FSH, LH and hCG

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 11 hours ago

Residents (LPR), and foreign nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program website for information about the valid immigration

FDA Postdoctoral Fellowship in New Approach Methodologies (NAMs)

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 11 hours ago

results, compare MPS-derived profiles with clinical data, and assess translational concordance. These efforts will include identifying factors that contribute to variability between in vitro and clinical

FDA Developmental Safety Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 11 hours ago

review process. Learning Objectives: Under the guidance of the mentor(s),you will develop the following skills during the fellowship; (1) data collection and analysis, (2) clinical pharmacology and

FDA Fellowship - Development and Validation of AI Prompts to Summarize Industry Submissions

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 11 hours ago

nationals. Non-U.S. citizen applicants should refer to the Guidelines for Non-U.S. Citizens Details page  of the program website for information about the valid immigration statuses that are acceptable

FDA Clinical Research Fellowship

Center for Drug Evaluation and Research (CDER) | Silver Spring, Maryland | United States | about 11 hours ago

methodology, and translational research design. The participant will develop competencies in good clinical practice (GCP) standards, clinical trial ethics, protocol development, pharmacokinetic data analysis

FDA Fellowship - Statistical Methods for Three-Arm Clinical Trials with Multiple Testing Procedure

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 18 days ago

group. The conventional Dunnett’s type I error rate adjustment proposed in 1955 is for superiority tests with normally distributed data. There are statistical concerns about generalizing the procedure