Yi-Jing Duh

Yi-Jing Duh, PhD is a senior statistician and head of statistical services in the medical devices and pharmaceutical industry. She has overseen statistical planning for over 50 clinical studies, from study design, sample size calculations, analysis plans to CRF development, database design, development and validation, SAS programming and output, and presentation to regulatory agencies in support of PMA and NDA applications. She has collaborated with large and small start-ups in ophthalmic, cardiovascular, urology, respiratory, and oncology studies. In her career spanning over 30 years, Dr. Duh has been directly involved in PMA, 510(k) and NDA approvals for over 35 medical devices and pharmaceuticals in the US, EU, and Japan, has interfaced extensively with FDA clinical and statistical reviewers, and participated in FDA panel preparations.