Qing Liu, Ph.D. and ASA Fellow, is the Founder of Quantitative & Regulatory Medical Science, LLC. Currently, Qing is leading Statistical Science and Program Strategy at Amicus Therapeutics, which develops precision medicines for patients suffering from rare diseases.
Qing’s mission is to bring innovative methods and technologies to clinical trials by leveraging his rich clinical trial experience, extensive research and publications in innovative design and statistical methods, and IT expertise in cloud based parallel- and super-computing.
Qing is a statistical expert who gained rich experience in broad disease areas in oncology, neurology, psychiatry, pain, cardiovascular, anti-infective, anti-virus, immunology and metabolic diseases from employment in academic institution, regulatory agency (FDA) and the bio-pharmaceutical industry. Qing’s clinical research experience includes more than 30 due- diligence projects in new drug licensing & acquisitions, numerous successful dispute resolutions with the FDA, successful implementation of various regulatory acceptable innovative trial designs and strategic clinical development planning. Qing has substantially contributed to clinical trial design, protocol review, monitoring, analysis, study report and regulatory submission.
Qing provided expert consulting for small and startup companies in efficient clinical development of innovative therapies with emphasis on medical devices, immuno-oncology, breakthrough designation drugs, rare disease therapies, and individualized medicine. To address the unique challenges in these areas, Qing specializes in blinded data monitoring (BDM) using an efficacy response signature (ERS) approach to adjust sample size and optimize statistical power for ongoing trials and in developing information enriched composite endpoints for use in efficient adaptive designs.
Qing has extensive publications in statistical research for innovative clinical trial designs and in medical research through broad collaborative research with statisticians in academics, the National Institute of Health (NIH), and top tier pharmaceutical companies. Qing has the foresight to develop an evidential paradigm for statistical inference in response to recent ASA’s formal statements on p-values.
Qing’s recent work at Amicus focuses on innovative trial designs and statistical analyses for rare disease drug developments. This includes randomized delayed start design with an integrated analysis of efficacy as well as a randomized controlled trial with internal comparative real world evidence.
Qing was named a Fellow of the ASA in 2013. Qing was a Sr. Research Fellow of Janssen R&D, J&J; Head of Biostatistics at Cephalon, Inc.; Senior Statistician at RWJ PRI of J&J; Mathematical Statistician at the FDA/CDER/DB1. Qing started his career as a Faculty at St. Jude Children’s Research Hospital.