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.
By This Author
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.
- Douglas E. Faries is Senior Research Advisor at Lilly USA, where he oversees statistical design and analysis support for Health Outcomes Research.
- Michele M. Burlew designs and programs SAS applications for data management, data analysis, report writing, and graphics for academic and corporate clients.
- Kevin D. Smith has been a software developer at SAS since 1997.