Statistically Speaking Consulting

David Lewin, Ph.D.

Biostatistician with 15+ years of experience in clinical development and pharmaceutical research.

I partner with life sciences and consumer products companies to bring rigorous statistical thinking to clinical trials, regulatory submissions, and complex data problems. My work spans the full development program from study design through reporting, with a focus on methodology, cross-functional collaboration, and clear communication of results.

Areas of Expertise

Clinical Trial Design & SAP Writing
SAS & R Programming
ADaM / SDTM / TFLs Validation
Regulatory Submission Support
Integrated Summaries (ISS / ISE)
Ad Hoc & Exploratory Analyses
Simulation Studies
R Shiny Applications

Representative Clients

Theravance Biopharma Janssen Pharmaceuticals Johnson & Johnson Consumer L'Oréal La Roche-Posay Henkel Neutrogena Kraft Foods Philadelphia Eagles

Education

Ph.D. in Statistics University of Pennsylvania, The Wharton School
B.S. in Operations Research & Industrial Engineering · summa cum laude Cornell University, College of Engineering
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