SELECT * FROM sessions where years='2017' and sequence=120
December 4-8, 2017 at Atlantic City, New Jersey
The 73rd Deming Conference on Applied Statistics
Sponsored by Metropolitan Section, ASQ and Biopharmaceutical Section, ASA
   
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Multi-Regional Clinical Trials and the ICH E17

Speaker(s): Dr William Wang (Merck)
Dr Yuki Ando (PMDA)
Moderator: Kalyan Ghosh
 

Dr. William (Bill) Wang is an executive director, clinical safety statistics, in the department of Biostatistics and Research Decision Sciences (BARDS), Merck Research Laboratories. He has over 20 years of experience in the pharmaceutical industry, with expertise and research publications in statistical design, analysis, clinical data management and their technology enablement. During his 15-year tenure at Merck, he supported regulatory filings in multiple therapeutic areas and established the BARDS Asia Pacific operation. Since 2010, he has served on the DIA China Regional Advisory Board and the DIAís Global Community Leadership Council (CLC), including the chairmanship of the DIA China Statistics Community. He was a recipient of the DIA global inspire award award in 2012. He is currently chairing an ASA safety monitoring working group, and a deputy topics-leader in the ICH E17 working group on multi-regional clinical trials.

Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan.

She received a masterís degree in Engineering from Tokyo Science University, and PhD in Health Science from Osaka University.

In 1997, she joined 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 in the new drug and device review offices in PMDA. Additionally, she works as a leader of business part of Advanced Review with Electronic Data Promotion Group, the group which is responsible for the use of patient level electronic study data that are submitted with new drug applications in Japan. She is responsible for promoting CDISC implementation and the use of submitted electronic data in new drug review in PMDA.


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