Manager, Data Intelligence, Biostatistics & Data Management
Daiichi Sankyo Co., Ltd.
This spotlight was featured in June 2019.
Yumiko led the CDISC Japan User Group (CJUG) ADaM team from 2011 - 2018, who produced the Japanese ADaM summary document for learners (Hajimete-no-ADaM).
How long have you been volunteering at CDISC?
For 11 years. I have been volunteering on the CDISC Japan User Group (CJUG) ADaM team since 2008, and led the team for eight years (2011-2018).
What encouraged you to volunteer your time and expertise with CDISC?
I encountered CDISC Standards, SDTM and ADaM, when I joined Amgen as a biostatistician in 2006. I was really fascinated how CDISC standards streamlined the statistical analysis process and enabled us to work globally on a company-wide biostatistics/statistics programming team under standard governance.
I started volunteering with CJUG to share my experiences of CDISC implementation and discuss solutions with considerations on Japan-specific settings.
How did you begin working in clinical research?
I majored in statistics and quality management in my undergraduate and graduate at university, and wanted to utilize my knowledge and expertise for health care in the world. Thus, I joined the pharmaceutical industry.
What did you want to be when you grew up?
I wanted to be a musical theorist because I liked both mathematics and music.
Tell us about working on the ADaM Summary document Hajimete-no-ADaM.
It is our pleasure that our Japanese ADaM summary document for learners (Hajimete-no-ADaM) is now available on the CDISC website. In close collaboration with the CDISC ADaM team, the CJUG ADaM team developed this document to eliminate linguistic barriers according to COP 007 to ensure quality of the content.
This accomplishment was brought under the strong leadership from the CJUG ADaM team including translation Sub-team Lead Masataka Sano (Chiba Institute of Technology), Quality Control Sub-team Lead Hisae Watanabe (Ono Pharmaceutical), and Global Communication Officer Koichi Yamaguchi (Lilly).
We are so grateful to CDISC ADaM Team members, John Troxell (Data Standards Consulting Group), Jack Shostak (Duke Clinical Research Institute), Sandra Minjoe (PRA Health Sciences) and public reviewers for their kind, helpful and thoughtful review comments, and J3C Chair Hidetoshi Misawa (Pfizer), Joe Ben Clark (CDISC), and everyone who were involved in the review process.
We really hope this concise and user-friendly document written in Japanese will help novice ADaM users in Japan implement the standard smoothly.
Please provide a tip that someone would find helpful in working with CDISC Standards.
It would be essential to transcend linguistic barriers for non-English speaking people engaged in clinical research. There are always some challenges when we communicate globally or even locally due to differences of language, culture, or regulation, etc. I believe the CDISC Standards are not just standards but a strong communication tool in our industry. The CDISC Standards, as a common language, will enable us to overcome these challenges to collaborate locally and globally!