Senior Scientist for Biostatistics
Dr. Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan.
She received a master’s degree in Engineering from Tokyo Science University, and PhD in Health Science from Osaka University. In 1997, she started her career as a Biostatistics Reviewer at the Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), which was established that year and subsequently transformed into the current PMDA.
Currently she is responsible for the biostatistics review and consultation of new drugs and new devices as the group leader of Biostatistics Reviewers. She has a lot of experiences of ICH guidance development such as E9(R1) and E8(R1). She is a member of the Global Clinical Study Working Group which is one of the projects across multi-offices in PMDA and helps implementation of the related guidance including ICH-E17.