Education
- 2020 ~ 2022 Duke University, MS.Biostatistics
- 2016 ~ 2020 University of Waterloo, BS.Mathematical Finance & Statistics
Experiennce
- 2022.06 ~ current
Eli Lilly and Company, Statistician- Provided statistical programming expertise for multiple Phase II and Phase III studies on Alzheimer’s disease treatments, contributing to FDA approval
- Prepared SDTM datasets, ADaM datasets, and TFLs (Tables, Figures, Listings) using SAS and R for interim deliveries, DMC meetings, and annual safety reports (DSURs)
- Supported FDA Advisory Committee requests, including real-time table generation during live meetings, and efficiently responded to regulatory requests from FDA, EMA (European Medicines Agency), and PMDA (Japan: Pharmaceuticals and Medical Devices Agency). Generated hundreds of tables related to TEAE (treatment-emergent adverse event), Exposure, and Vital Signs often under tight deadlines (48-72 hours, or overnight turnaround)
- Led a prospective observational study, ensuring alignment with study objectives, and served as a co-author of the study publication
- Reviewed SAPs, protocols, and annotated CRFs for clarity and consistency; drafted specifications for SDTM and ADaM datasets to ensure compliance with CDISC standards
- Effectively coordinated with project statisticians, data analysts, and medical teams, resolving raw data issues and ensuring on- time study deliverables
- Created an R Shiny application for bulk study folder creation on the company’s clinical data platform, streamlining workflow and improving organization
- Developed custom R and SAS reusable code modules to enhance team efficiency and quality control
- Lead organizer of a monthly session to mentor around 20 junior statistical analysts, fostering skill development and knowledge-sharing within the team
- 2021.09 ~ 2022.05
Duke University School of Medicine, Research Assistant - 2021.09 ~ 2022.05
Duke Molecular Phisiology Institute, Statistician Intern - 2021.04 ~ 2021.08
Sanofi, Shanghai, Analyst Intern