Lisa Thackeray brings over two decades of biostatistics expertise to support medical device innovators in achieving regulatory success. As Senior Principal Biostatistician at NAMSA, Lisa provides strategic guidance across all phases of clinical research, from protocol development to final reporting.
Lisa’s experience spans a wide range of therapeutic areas, including cardiology (congestive heart failure, electrophysiology, interventional), chronic venous disease, embolization, nephrology, neuroimmune modulation, neurology, ophthalmology, orthopedics, pediatrics, and infectious disease. She has led statistical efforts for multiple international trials, delivering high-quality tables, figures, and analyses for regulatory submissions, peer-reviewed publications, and scientific conferences. Her expertise also includes compiling and presenting Data Safety Monitoring Board (DSMB) reports and serving as a statistician on DSMBs.
Known for her clear communication with clients and regulatory authorities, Lisa helps navigate complex statistical and regulatory challenges with confidence. She has contributed to FDA Bioresearch Monitoring (BIMO) inspections, developed and reviewed SOPs, and supported quality initiatives across cross-functional teams.
Before joining NAMSA in 2012, Lisa held biostatistics roles at The Integra Group and conducted academic research at the University of Minnesota Division of Biostatistics. She earned her MS in Biostatistics from the University of Minnesota and BA in Mathematics with a concentration in Statistics from the University of Minnesota–Morris. Lisa is an active member of LifeScience Alley and the Medical Device Alliance and is a Delta Omega Honorary Society inductee in Public Health.
CORE COMPETENCIES
- Communicating with clients and regulatory authorities regarding statistical design and analysis issues
- Supporting clinical team with FDA or other regulatory bodies’ submissions (De Novo, 510(k), sPMA, PMA, etc.) and responses to statistical questions
- Preparing Statistical Analysis Plans, table shells, analysis specifications, and statistical reports
- Providing data analysis, tables, and graphics for statistical reports provided to researchers and regulatory authorities
- Developing SAS programs to create derived variables and analysis datasets and programs to generate listings, tables, and graphs using SAS
- Developing analysis dataset specifications/documentation
- Performing program and report validation by independent coding or code and log review
- Preparing statistical sections of protocols, performing sample size and power calculations for studies, and creating randomization schedules per study design and relevant specifications
- Compiling data safety monitoring board (DSMB) reports and organizing/running DSMB meetings
- Served as statistician on DSMB
- Co-authoring peer-reviewed journal articles
- Providing tables, graphics, and statistical expertise for scientific conference presentations and journal publications
- FDA BIMO inspection support
- Development and review of department and cross-functional SOPs
- FDA Advisory Committee panel meeting sponsor support
RECENT PROJECTS
- Delivered statistical programming, analysis, and strategic advice for a regulatory submission of an embolization device, contributing directly to successful FDA approval.
- Led the statistical strategy and planning for a chronic venous disease device in support of an IDE application, ensuring methodological rigor and regulatory alignment.
- Provided programming and statistical support for multiple orthopedic post-market studies, including annual reporting for international regulatory authorities.
