Extensive Experience. Proven Execution.
Rutgers University, Ph.D. in Biostatistics
Tsinghua University, BS in Electrical Engineering and Industrial Engineering
19 years of industry experience, worked at Pfizer and Roche
2003-2010 Founded a statistical consulting firm in the US
2010-2016 Head of the K&L data and statistics division
2013-2016 COO and CEO of Fountain Medical Development
Led and completed more than 25 statistical and analysis projects in FDA/EMA NDA applications.
National Taiwan University, Bachelor Clinical Medicine
National Taiwan University, Internal medicine resident
Vanderbilt University, Clinical Pharmacology, Researcher Fellow
Vanderbilt University, Clinical Medicine Cardiovascular, Clinical Fellow
Vanderbilt University, Cardiac electrophysiology, Clinical Fellow
Arkansas Heart Hospital, Cardiovascular and Cardiac Electrophysiology, Senior Cardiologist.
Engaged in the clinical diagnosis and treatment of cardiovascular and cardiac electrophysiology since 1994
As a lead investigator, completed and participated in a number of clinical studies for FDA submissions since 1988
Jiamusi Medical College, Bachelor of Pharmacy
27 years of industry experience, 18 years of regulatory registration experience and 9 years of preclinical research and development experience
Deputy Director, Director and Senior Director of Fountain Medical Pharmaceuticals Registration Department
Successfully filed IND and NDA applications for dozens of chemical and biological products as well as imported drugs. Participated in early clinical development for dozens of innovative drugs as a strategic advisor.
Registered hundreds of pharmaceutical products
Successfully completed US-China dual registration for multiple products
Peking University School of Medicine, Pharm.D
11 years of pharmacokinetics research, regulatory experience and bioanalytical management experience, including ADME screening platform, IND DMPK filing, and regulatory bioanalysis to support GLP toxicology and clinical research
Vice President, DMPK and Regulatory Bioanalysis, Pharmaron
Head of Clinical Bioanalytical Testing Laboratory, Pharmaron, with extensive experience in the fields of biotransformation, ADME, and drug-drug interaction
Familiar with pre-clinical and clinical registration of innovative drugs with NMPA and FDA submissions
Xi’an Jiaotong University, Master of Bioengineering, Genetic Statistics
Xi’an Jiaotong University, Bachelor of Bioengineering
Over 10 years of biostatistics and programming experience.
Pharmaceutical Biostatistics Manager, Senior Manager and Director in MacroStat, Fountain Medical Development.
Responsible for statistics and programming of multiple Phase I to IV international and domestic projects (involving different therapeutic areas), 2 US NDA submissions and multiple Chinese NDA submissions.
North Carolina State University, Ph.D. in Biostatistics
National Chengchi University, MBA in Statistics
National Taiwan University, Bachelor of Mathematics
Over 18 years of experience in biostatistics industry.
Senior Statistician, Deputy Director of Statistics, Director and Senior Director in Merck, FMD K&L.
Participated in multiple FDA NDA submissions across various therapeutic areas.