About me
Lisa Kammerman, PhD, owner of Kammerman Consulting, draws upon her industry and FDA experience, and provides statistical regulatory expertise and endpoint development guidance to pharmaceutical projects advancing to regulatory interactions and submissions. At AstraZeneca, as a Senior Statistical Science Director and Regulatory Specialist, she advised teams and wrote a guidance document on the analysis and interpretation of studies that use PROs. In her 24-year career as a biostatistical Master Reviewer and Team Leader in the Office of Biostatistics, CDER, FDA, she oversaw the Office’s Clinical Outcome Assessments program, and facilitated policy for the study design/analysis/interpretation of studies that use COAs.
