27 parallel-processing-bioinformatics "https:" positions at Center for Drug Evaluation and Research (CDER)

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 | 2 days ago

experiences in regulatory decision-making processes. You will also engage in professional development seminars on scientific writing for regulatory audiences and presentation skills for technical and policy

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

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

the potential to streamline immunogenicity testing by consolidating the multi-tiered process into a single, more efficient method. While the signal-to-noise ratio approach demonstrates clear advantages

FDA Dosing of Cancer Drugs in Obesity

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | 2 days ago

designs in various patient populations and understand the regulatory implications of dosing recommendations. Understanding of FDA's drug review process, particularly regarding clinical pharmacology

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 24 hours ago

process Master the bioanalysis of PD biomarker guidance and best practice in industry Understand the scientific considerations in regulatory decision making Through your training, you will be able

FDA Fellowship - Assessing Rare Safety Signals in Psychiatric Clinical Trials

Center for Drug Evaluation and Research (CDER) | Southern Md Facility, Maryland | United States | about 24 hours ago

therapeutics and generic drugs. These efforts cover more than just medicines. Research Project: Safety assessments for medications intended to treat psychiatric conditions present unique challenges in signal

FDA Evaluating the Pharmacokinetic Profile of Long-Acting Injectables in Pregnant Individuals

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

interpretation of clinical/model-based PK data in the context of dosing and safety; 3) Collaborate with PBPK experts both within and outside the FDA; 4) Gain an understanding of the drug regulatory review process

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 | 2 days ago

review through an immersion into nonprescription regulations and the processes of nonprescription drug evaluation and approval. Qualitative and quantitative analytical skills will be honed. You will learn

FDA Biomarker Qualification Fellowship

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

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 | 2 days ago

culture, cell transduction, single cell cloning, cell banking, etc. Perform hands-on studies to learn the procedure to optimize and qualify cell-based bioassays. Perform hands-on studies to compare in vitro

FDA Large Language Models (LLM) for Case Definition Classification Fellowship

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

models (LLMs) to enhance case definition processes by developing a prototype that demonstrates the capability of LLMs to accurately categorize and classify case definitions. The selected fellow will