Regulatory agencies, and both small and large pharmaceutical and biotechnology companies. He was first introduced to CDISC while working 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 FDA review team and invented an early version of the MAED Service, an adverse event review tool that made use of data standards and is currently in production at the FDA. Since leaving the FDA, 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, a BS in statistics from Virginia Tech, and is an Accredited Professional Statistician™ by the American Statistical Association.
When Jack Shostak and I first started thinking about writing a SAS book on implementing CDISC (Clinical Data Interchange Standards Consortium) standards, we held one truth to be self-evident: that at least some parts of the book would be outdated before it was even published. Thanks to some lucky timing
