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Erik Pulkstenis, PhD

North Chicago, Illinois,
Erik Pulkstenis joined AbbVie in 2018 as the Vice President and Head of Data and Statistical Sciences in support of clinical development strategy, data science/analytics, statistical analysis and reporting, data operations, and digital science. Erik has more than 20 years of experience in drug and device development and clinical research. He has experienced success building, rehabilitating and leading biometrics departments including organizational design and operating model definition/implementation. He is also passionate about organizational leadership and culture. He has more than 25 peer-reviewed publications including one textbook and has directly supported 14 FDA approvals.
Previously, Dr. Pulkstenis headed Clinical Biostatistics & Data Management at Medimmune, where he established the organizational infrastructure, underlying operating model and all associated processes in support of a diverse pipeline focused on immunology, immuno-oncology, and cardiovascular disease. Prior to that, Dr. Pulkstenis led the Biostatistics Department at Human Genome Sciences and served at C.L. McIntosh & Associates consulting with medical device manufacturers with respect to study design, regulatory strategy, and FDA Advisory Committee preparation.
Dr. Pulkstenis served from 2013-2019 on the American Statistical Association Biopharmaceutical Section Executive Committee and currently serves on the ICH E20 Adaptive Design Expert Working Group and CDISC Board of Directors.
Dr. Pulkstenis received an M.S. and Ph.D. in statistics from the Pennsylvania State University.
Speaking In
12:00 PM - 12:45 PM (EDT)
Tuesday, June 15

How we conduct clinical trials has been evolving as a result of new technologies and tools …