Shein-Chung Chow, Ph.D. is an Associate Director, Office of Biostatistics, CDER/FDA. Prior to joining FDA, Dr. Chow was a Professor of Biostatistics and Bioinformatics at Duke University School of Medicine, Durham, NC. He was also a special government employee (SGE) appointed by the FDA as an Advisory Committee member and consultant to the FDA. Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Editor-in-Chief of the Biostatistics Book Series at Chapman and Hall and CRC Press. Dr. Chow is Fellow of the American Statistical Association, who is the author or co-author of 300 methodology papers and 29 books.