Michael Burak, MS is a biostatistician and SAS programmer with over 15 years of experience in the pharmaceutical and medical device industries. His areas of focus include SAS programming, exploratory data analysis, statistical modeling, and predictive and simulation analytics. He generates FDA submission deliverables including tables, figures, and listings (TFLs) for efficacy/effectiveness and safety analyses and statistical writing for clinical study reports which conform to CDISC’s essential standards (SDTM and ADaM). He has helped numerous companies obtain successful FDA clearances and approvals in various therapeutic areas. Mr. Burak also has experience working with CROs and has served as a member of multiple DSMB/DMC committees.
Regulatory Pathways Group Inc.
a California corporation
Inquiries and general information:
info@regulatorypathways.com
