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. It was there where he served as the technical lead for the SDTM/ADaM Pilot Project review team at the FDA, which was a team of FDA staff involved with assessing the suitability of CDISC standards for meeting the needs of medical and statistical