Shuguang Huang, PhD

Dr. Huang received his BS in Probability and Statistics from Beijing Normal University and his PhD in Statistics from the Northwestern University.  Dr. Huang spent the first 10 years of his career at Eli Lilly and Wyeth/Pfizer where he led a group of statisticians supporting preclinical studies and clinical biomarker studies. Then he joined a cancer diagnostics company, Precision Therapeutics Inc., as the Associate VP leading the bioinformatics group.

In 2014, he co-founded the statistics consulting company Stat4ward LLC, which works with pharmaceutical and medical device companies, supporting CDx and IVD/LDT product developments. Dr. Huang has rich experience in PMA and 510k submissions. He has deep expertise in both analytical validation and clinical validation of IVD/LDT products. He is actively involved in multiple CLSI guideline development committees.