Clinical Trial Statistics Expert Witness
A Ph.D. biostatistician with phase I–IV design and analysis experience across vaccine, rare-disease, and cardiovascular-device programs, and a former FDA statistical reviewer. Dr. Li provides independent statistical opinions on the design, conduct, and analysis of clinical trials in litigation, available to plaintiff and defense counsel.
- Former FDA/CDRH statistical reviewer
- Phase I–IV trial experience
- SAS · R · Python
- Plaintiff & defense
Clinical-trial disputes Dr. Li addresses
Statistical questions frequently at issue when the design or analysis of a clinical trial is challenged in litigation.
- Endpoint definitions and analysis populations (ITT, per-protocol, modified ITT)
- Efficacy and safety analyses, including adverse-event incidence
- Randomization, allocation concealment, and blinding
- Interim analyses, data-monitoring decisions, and stopping rules
- Multiplicity and control of the family-wise error rate
- Missing-data handling and mixed-model repeated-measures (MMRM)
- Bayesian, adaptive, and group-sequential designs
- Sample-size determination, power, and re-estimation
- Protocol and statistical-analysis-plan (SAP) deviations
How Dr. Li helps
From early case assessment through written reports and testimony, scaled to the needs of the matter.
Independent re-analysis
Reconstruction and re-analysis of trial data using SAS, R, or Python to test whether reported results follow from the data and pre-specified methods.
Methodology review
Assessment of trial design, endpoints, the SAP, and analytic choices against accepted statistical and regulatory standards.
Rebuttal of opposing experts
Critical review of an opposing expert’s statistical assumptions, models, and conclusions, with clearly stated points of agreement and disagreement.
Expert reports & declarations
Written reports and declarations that set out methods, assumptions, and conclusions in language a court can follow.
Deposition & trial testimony
Available to provide deposition and trial testimony, presenting statistical opinions clearly to judges and juries.
Relevant experience
Drawn from clinical-trial design and analysis across regulated drug, vaccine, and device programs.
At Sanofi, Dr. Li served as a statistical project leader on vaccine programs spanning translational and phase I/II studies through phase III, including dose-finding with MCPMod, Bayesian Decision-by-Design Go/No-Go criteria, a Bayesian group-sequential phase III design with efficacy and futility monitoring, and co-leadership of phase III rare-disease (hemophilia) studies with integrated summaries of efficacy and safety. At Edwards Lifesciences, he worked on cardiovascular early-feasibility studies, developing statistical analysis plans and applying mixed-modeling and win-ratio methods. As a former mathematical statistician and primary statistical reviewer at the FDA’s Center for Devices and Radiological Health (CDRH), he reviewed the statistical evidence supporting marketing and investigational submissions and authored statistical memoranda.
This regulatory and trial-design background informs opinions on whether a trial’s endpoints, analysis populations, and analytic methods were appropriate and were applied as pre-specified.
Dr. Li’s disclosed litigation engagements to date have been in a consulting-expert capacity. He is available for, and welcomes, testifying engagements, including expert reports, declarations, deposition, and trial testimony. Every engagement is subject to a conflicts-of-interest check.
Frequently asked questions
What kinds of clinical-trial cases do you take?
Matters that turn on the statistical design, conduct, or analysis of a clinical trial — including endpoint and analysis-population disputes, efficacy and safety analyses, interim-analysis and stopping decisions, multiplicity, missing data, and sample-size or power questions. Dr. Li accepts engagements from both plaintiff and defense counsel, subject to a conflicts check.
Can you re-analyze the underlying trial data?
Yes. Where the data and documentation are available, Dr. Li can reconstruct and independently re-analyze trial data in SAS, R, or Python to test whether the reported results follow from the data and the pre-specified statistical analysis plan.
Do you provide deposition and trial testimony?
Dr. Li is available to provide expert reports, declarations, deposition, and trial testimony. His disclosed engagements to date have been in a consulting-expert capacity, and he welcomes testifying roles.
How do you handle conflicts of interest?
Each potential engagement begins with a conflicts-of-interest check before any substantive work or agreement. An engagement is formed only upon a signed written agreement.
Discuss a clinical-trial matter
Tell us about the trial design or analysis at issue. Dr. Li will assess fit and run a conflicts check before any engagement.