2012 PB Implementing CDISC Using SAS: An End-to-End Guide by Holland, Chris; Shostak, Jack

Chris Holland has been a SAS user since 1990. He currently works as a Biostatistics Director for Amgen and has prior experience heading up biostatistics departments for Sucampo Pharmaceuticals, MacroGenics, and Micromet. He has also worked as a statistical reviewer at the Center for Drug Evaluation and Research in the U.S. Food and Drug Administration. There he served as the technical lead for the SDTM/ADaM Pilot Project review team, which included FDA staff involved with assessing the suitability of CDISC standards for meeting the needs of medical and statistical reviewers. Holland continues to be active in the CDISC community, particularly with the ADaM team. He received an MS in Statistics from the University of Virginia, and a BS in Statistics from Virginia Polytechnic Institute and State University. He is an Accredited Professional Statistician by the American Statistical Association.

Jack Shostak, Associate Director of Statistics, manages a group of statistical programmers at the Duke Clinical Research Institute. A SAS user since 1985, he is the author of SAS Programming in the Pharmaceutical Industry, and coauthor of Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, both published by SAS Press. Shostak has published papers for the Pharmaceutical SAS Users Group (PharmaSUG) and the NorthEast SAS Users Group (NESUG), and he contributed a chapter, "Reporting and SAS Tool Selection," in the book Reporting from the Field. Jack is active in the CDISC community, contributing to the development of ADaM and the Statistical Domain Analysis Model, and he serves as a CDISC ADaM trainer. He received an MBA from James Madison University, and a BS in Statistics from Virginia Polytechnic Institute and State University.