Greg Maislin is Principal Biostatistician of Biomedical Statistical Consulting, a CRO focusing on clinical trials of medical devices for regulatory review. He is also Adjunct Professor of Statistics in Medicine at the Perlman School of Medicine of the University of Pennsylvania where he leads the Biostatistics Core for the Division of Sleep Medicine. Professor Maislin has authored or co-authored over 200 medical research publications. An ASA member since 1983, he served on every nominating committee for SIGMEDD before the Special Interest Group became the MDD Section and was subsequently elected as MDD Section Representative to the ASA Council of Sections.
Past Program Chair: Tyson Rogers
Past Chair: Ted Lystig
Past Program Chair: Norberto Pantoja-Galicia
Norberto Pantoja-Galicia is a mathematical statistician in the Division of Biostatistics at the FDA Center of Devices and Radiological Health. He joined FDA after completing a post-doctoral research fellowship at Harvard University School of Public Health, Department of Biostatistics. He obtained his PhD in Statistics from the University of Waterloo, Canada, where he also worked as an instructor in statistics and completed a research fellowship in Statistics Canada. His interests include design, analyses, guidance writing and reporting of clinical studies to evaluate medical diagnostic devices in areas such as diagnostic imaging, infectious diseases, molecular genetics, medical countermeasures, as well as ROC curve methodology, complex survey data and benefit-risk analyses for diagnostics. Dr. Pantoja-Galicia has been a regular FDA presenter at Advisory Panel Meetings and is a member of the Editorial Board of Statistical Communications in Infectious Diseases (SCID). He received the 2015 American Statistical Association Medical Devices and Diagnostics Section Best Contributed Paper Award at JSM. Dr. Pantoja-Galicia has served as the 2017 program chair of the ASA MDD section.
Lead of (FDA/AdvaMed) Day 0 Conference Planning: Gene Pennello
Gene is a Team Leader in Diagnostics Statistics Branch 2 of the Division of Biostatistics at the FDA Center for Devices and Radiological Health. He is also a past chair of the ASA Section on Medical Devices and Diagnostics. Before joining FDA, was a postdoctoral training fellow at the National Cancer Institute, Division of Cancer Epidemiology and Genetics. He has a Ph.D. in Statistics from Oregon State University (1993), and a Master’s degree in Statistics from the University of California at Davis. His official area of expertise at FDA is application of statistics to the design and analysis of studies concerning diagnostic devices, with particular emphasis on drug-diagnostic co-development and the evaluation of imaging systems. For the ASA, Gene has served as chair and program chair for the Section on Medical Devices and Diagnostics. In 2016, Gene was selected as a Fellow of the American Statistical Association (ASA). His statistical interests include Bayesian analysis, multiple comparisons, missing data, measurement error, and benefit-risk evaluation.