Head of Biostatistics, Immunocore
Chris Holland has been a SAS user since 1990 in a variety of settings ranging from academia, contract research organizations, 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.
Implementing CDISC Using SAS®: An End-to-End Guide, Revised Second Edition
Comprehensive guide on applying clinical research data and metadata to the CDISC standards. This edition reflects the 2017 FDA mandate for adherence to CDISC standards. Revised to add the latest C-Codes as well as update the make_define macro that accompanies this book in order to add the capability to handle C-Codes.
By This Author
- Ron Klimberg, PhD, is a professor at the Haub School of Business at Saint Joseph's University in Philadelphia, PA.
- Bart Baesens is an associate professor at KU Leuven (Belgium) and a lecturer at the University of Southampton (United Kingdom).
- Jared Dean is the Chief Technology Officer of StepLeader.
- Jason W. Osborne, PhD, is an Educational Psychologist and Statistician and is currently Dean of the Graduate School at Clemson University.