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J Biopharm Stat
October 2016
a Lilly Corporate Center, Global Statistical Sciences , Eli Lilly & Company , Indianapolis , Indiana , USA.
Statistical principles and ongoing proliferation of novel statistical methodologies have dramatically improved the clinical drug development process. This journey over the last seven decades reshaped the pharmaceutical industry and regulatory agencies, highlighted the importance of statistical thinking in drug development and decision-making, and, most importantly, improved the lives of countless patients around the world. Some significant highlights in the history of this journey are recounted here as well as some exciting opportunities of what the future may hold for the science and profession of statistics.
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