Elizabeth Li is a member of the team that launched PharmaStat in 2005. Since 1992 she has provided statistical data analysis and data management services in the biotechnology, pharmaceutical, and healthcare research fields.
She brings value to clients in the planning for regulatory submissions, developing data analysis strategies, and providing statistical solutions. She has provided statistical data analyses of Phase 1 through 3 clinical studies, integrated summary of efficacy (ISE), and integrated summary of safety (ISS), which contributed to more than 20 regulatory submissions in the past 7 years. She has also represented clients in face-to-face discussions with FDA medical reviewers and statisticians. She applies CDISC data standards to produce analysis data and statistical reports.
Elizabeth’s experience includes serving as an in-house biostatistician for several start-up companies. In that capacity, she has performed a variety of functions: developing protocols, writing statistical analysis plans, designing analysis databases, performing planning and exploratory data analyses, and providing vendor oversight and quality assurance.
Areas of expertise for Elizabeth Li:
- Protocol development, including sample size and power estimation
- Statistical analysis and programming
- CDISC ADaM standards implementation for analysis and reporting