Yuki Ando, PhD
Yuki Ando is a Principal Senior Scientist in Biostatistics at the Pharmaceuticals and Medical Devices Agency (PMDA). With over 25 years of experience as a Biostatistics Reviewer, she is currently responsible for biostatistics review and consultation in the new drug offices at PMDA.
Since 2013, when discussions began in Japan about requiring the submission of patient-level clinical study data in CDISC standardized format as part of new drug applications, she has been deeply involved in the project. To date, she has contributed to various aspects of this electronic data submission initiative, including the development and dissemination of regulatory guidance documents and validation rules, the review and decision-making process regarding dataset acceptance or rejection, and coordination with key stakeholders such as pharmaceutical industry associations, CROs, and academic organizations. Additionally, she has experience in the development of ICH guidelines, including E9(R1), E8(R1), and E20, as a member of the Expert Working Groups.
Yuki holds an M.Sc. in Engineering from the Tokyo University of Science and a Ph.D. in Health Science from Osaka University.