Shuguang Huang, Ph.D.

Statistical Methods Biomarker, IVD/LDT, Clinical Development
Shuguang

Shuguang Huang, Ph.D.

statistics, statistical, manufacturing, diagnostics, biomarker, diagnostics, ASSAY development, validation, companion, FDA, global regulatory submissions, CMC, processes control, pre-clinical, toxicology, Data science, startups
Statistical Methods Biomarker, IVD/LDT, Clinical Development

Chief Scientific Officer, Stat4ward

Dr. Huang has approximately 20 years of experience working in pharmaceutical and diagnostic companies. He held technical and management positions at Eli Lilly, Wyeth, Pfizer, and Precision Therapeutics, a cancer diagnostic company. In 2014, he co-founded and assumed the position of the Chief Scientific Officer for Stat4ward LLC, a statistics consulting company. Stat4ward works with over 20 pharmaceutical, device, and diagnostic companies.

Dr. Huang’s expertise includes in-depth knowledge of theory and application of statistical methods for assay development and validation, biomarker and companion diagnostics product development and global regulatory submissions, CMC and statistical process control, as well as pre-clinical and Phase I-IV clinical development.

As a well-recognized expert in biomarker analytical method development and validation, Dr. Huang has been involved in the development of scientific guidelines by the American Association of Pharmaceutical Scientists and Clinical Laboratory Standard Institute. He holds a Ph.D. in Statistics from Northwestern University.