Yang Yang
VP, Head of Biometrics at Ardelyx, Inc.
- Role
- VP of Biometrics at Ardelyx, Inc.
- Location
- Fremont, CA, US
- LinkedIn followers
- 500 followers
About Yang Yang
12-year drug/device development experience as a Lead Statistician of Phase I to Phase IV studies • 4-year regulatory experience as a statistical reviewer of IND/NDA submissions at FDA/CDER • Extensive experience with regulatory authorities including FDA, EMA, Health Canada, and Singapore HSA • Participated in an FDA Advisory Committee Meeting, a CHMP Scientific Advisory Group/Ad-Hoc Expert Group meeting, and an Oral Explanation • Experience with 3 NDA submissions across 3 different therapeutic areas and 1 PMA • Led the preparation of an NDA submission for a rare disease as a Lead Statistician, Medical Writer, and Vendor Coordinator, and finalized high-quality clinical documents within extreme timelines • A Multiplier with 9 years of managerial experience in developing Biostatistics/Biometrics, managing CROs, and leading the Biometrics team to successful deliveries under limited resources and stringent timelines • Excellent analytical, SAS programming, and medical writing skills • Attention to details
Experience
VP of Biometrics
Jan 2022 — Present · Fremont, CA, US
Education
Wuhan University
BS (Minor)
State University of New York at Stony Brook
Ph.D.
Wuhan University
BS
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