Lei Li

Lei Li, PhD is a biostatistics expert specializing in FDA clinical trial processes and statistical methodologies. With a career encompassing pharmaceutical statistics, regulatory submissions, and advanced statistical designs, he brings a robust analytical framework to litigation work. His work centers on investigating statistical validity, assessing regulatory compliance, and evaluating whether clinical trial designs meet industry standards.

Mr. Li has been retained in numerous expert witness and consulting engagements across the United States, involving pharmaceutical and medical device cases. His PhD in Statistics from George Mason University, along with his Master in Statistics and dual Bachelor's degrees in Math and Finance from Shandong University, reinforce his ability to deliver objective, defensible analyses. He is regularly engaged by both plaintiff and defense counsel to provide clear, independent determinations of causation in disputes involving clinical trial methodologies and statistical evidence.