1. Collaborate with clinical reviewers in the Office of New Drugs (OND) within the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) to conduct safety data analyses for new drug applications (NDAs) and biologics license applications (BLAs). 2. Provide expert analysis of safety data collected during clinical trials, including adverse events, laboratory abnormalities, and serious safety issues applying a range of statistical tools and coding techniques to analyze the data, identify trends and patterns, and provide insights to the clinical teams. 3. Ensure that the safety data analysis reports presented are accurate, reliable, and compliant with regulatory standards.

• Expertise: NGS omics data and clinical data 1. Extensive experience collaborating with clinicians and scientists, providing consultation, and communicating data principles and concepts with multi-disciplinary teams at federal government (NIH, NSF), private foundation (Gates Foundation), and industry collaborators.2. Lead and develop data wrangling approaches to answer specific biomedical questionso Reviewing data sufficiency and integrity, conducting in-depth data analyses, verifying data generated by the clinicians or collaborators, and generating scientific reports and publicationso Data cleaning and structuring to identify and remove syntax error, missing or irrelevant data, outliers, duplications, etc. and to enhance data consistency and quality.o Data integration to link human clinical data to different biomedical data (e.g., genomic, serum protein, human biopsies, human microbiome, and gene expression data)3. Develop and troubleshoot analysis pipelines for NGS omics data o Identify gut host-microbe interaction after perturbation (longitudinal data analysis)o Identify survival and gut fungal infection in KO vs WT mice (time-to-event analysis)o Correlate clinical variables and antibiotics drug effect (correlation analysis)o Predict important features of NGS data (machine learning)o Identify clinically relevant genes & pathways for drug candidate MOA (network analysis) • Supervisor: Martin Boyer Professor of Medicine Eugene B. Chang, Ph.D., M.D.• Funding: NIH, and contracted foundations and companies

• Expertise: Microbiology, Microbial Ecology, Bioinformatics, Genomics • Focus: 1. Design and execute large-scale microbiome studies 2. Perform wet-bench genomics/molecular biology techniques (DNA/RNA libraries) 3. Analyze microbial genomic data (ordination analysis, correlation analysis, network analysis)• Funding: NSF, Bill and Melinda Gates Foundation, Water Research Commission of South Africa

• M.S. and Ph.D. in Engineering & Biotechnology • Focus: Molecular microbiology, Deep sequencing data, Deep sequencing data analysis• Mentor: Professor, University Faculty Scholar Francis L. de los Reyes III, Ph.D.