CDISC instructors come from a variety of professional backgrounds and are located across seven countries and three continents. Our instructors work for pharmaceutical companies, CROs, consultancy firms, academic institutions and undergo a rigorous qualification process to teach CDISC-authorized courses.
Kiyomi Ando is a clinical data manager (CDM) with 15+ years of experience working in a global pharmaceutical company, a Japanese pharmaceutical company, and a Japanese clinical research organization (CRO). She has been in charge of data management in 50+ clinical studies and has designed 20+ CRFs. She has participated in the CRF standardization project in a global pharmaceutical company. Kiyomi has implemented CDISC Standards in a CRO and a pharmaceutical company in Japan since 2005. She has also experience as a clinical research associate in a global pharmaceutical company and as a pharmacist in hospital. She has knowledge of the process from data acquisition in hospital to study data tabulation for submission.
Yoshihiro Aoyagi is the section head in Information Technology Management Section at National Cancer Hospital East in Japan. His main areas of expertise are system integration of infrastructure, data management and consultation for clinical trial systematization. He developed various information systems such as open source EDC system or Remote SDV system to improve utilization of information resource in the hospital. Yoshihiro has also researched the usage of hospital information system data and estimate its reliability and transparency. Previously, he had worked for clinical pharmacist drug information specialist.
Dehong Cao is Vice President of eClinWise Data Science (subsidiary of Beijing PANACRO Technology Co., Ltd) in charge of the clinical database and statistical analysis programming departments. Previously he worked at MSD China as Associate Director of SDTM Mapping & Clinical Data Reporting. He has 10+ years extensive experience in clinical database & SAS programming at Sanofi, MerckSerono, and MSD. He also have 3 years experience in graphics chip architecture design at S3 Graphics, Inc.
Dehong started using CDISC standards in 2008 and has rich hands-on experience with SDTM, ADaM, and Define-XML standards implementation for all phases of clinical trials.
Dehong has an M.S. in Computer Science from the Xi'an Jiaotong University, and a B.S. in Mathematics from Lanzhou University in Lanzhou, Gansu province of China.
Yanli Chang is a clinical programmer in Novartis with over ten years’ experience in data analytics and project management. She is actively involved in TA standards development by providing statistical programming input from data collection to SDTM, and also acts as a subject matter expert of ADaM to share the best practice and provide guidance.
Yoshiteru has been implementing CDISC standards using ODM and SDTM since 2008. These implementation activities include creating a link from the hospital electronic health record (EHR) system to the University Hospital Medical Information Network (UMIN) clinical research system using CDISC ODM, with the goal of improving clinical data quality using the CDISC standards. Yoshiteru has been teaching CDISC topics in the University of Tokyo School of Public Health (UT-SPH) since 2014.
Kunihito Ebi has been an IT Consultant at Fujitsu working for the pharmaceutical industry for the past 14 years. His main areas of expertise are clinical data standards, content management, regulatory submission, and compliance. Since the year 2000, Kunihito has also been Java/XML programmer and developed a free Define.xml generation tool. Kunihito Ebi has been a member of CDISC Japan User Group since 2013. He has been a product manager of CDISC-based metadata management system at Fujitsu since 2015.
Masaaki Imasho is project data manager in clinical data management in MSD K.K. and is participating CDISC user group in Japan. He has been working in pharmaceutical industry more than 25 years. He is experienced project manager and clinical data manager in various therapeutic areas.
Kumiko Kimura is Biostatistical Programming Manager at Amgen Astellas BioPharma and has 13 years of experience in clinical statistical analysis and programming. She has experienced project leading, creating SAP and mock-up shell, programming analysis datasets, creating define.xml and Analysis Data Reviewer’s Guide (ADRG) as well as consulting ADaM implementation. Kumiko is also a member of CDISC Japan User Group (CJUG) since 2009 and expands the use of ADaM in Japan.
Taku Shimizu is currently an analyst at Quintiles Transnational Japan K.K. He has been a SDTM specialist for 5 years with practical experience of SDTM development (40+ protocols) and implementation with multiple pharmaceutical companies.
He has managed all aspects of the SDTM, recently with define.xml, development and operation processes (schedules, designs, productions, tests, releases, editorials and maintenances) with efficiency. His skills are SAS, Pinnacle 21, and coordinating Data Manager and Biostatistician peacefully in a view of SDTM Specialist.
Taku joined LAB team in 2006. Since 2009, he has been an active member on the SDTM team. He earned a B.S. in Biochemistry from the Kyoto Institute of Technology.
Akira Soma is a principal solution consultant at Oracle Health Sciences Global Business Unit with over three years’ experience in both clinical development and pharmacovigilance. He has over 15 years of experience working in the pharmaceutical industry both in Japan and the United States primarily focused on clinical data management and IT. Prior to joining Oracle, he was a manager of data management/IT at Mitsubishi Tanabe Pharma Development America and the work he had done included governing, developing SOPs/WIs, and implementing SDTM standards within the company. Akira Soma has been involved with the Japan CDISC User Group SDTM team for more than 10 years, and has been active in a couple of PhUSE CSS Working Groups.
Satoshi Ueno is a senior researcher in the Center for Public Health Informatics at the National Institute of Public Health (NIPH). He has been involved in clinical research as a data manager and clinical research associate since 2004 and carried out basic research in molecular biology and biochemistry since 2006. Satoshi has worked in academia, national institutes, national center and a global contract research organization in Japan.
He holds a master’s degree and a doctoral degree in biological science from the University of Tsukuba. Satoshi is a member of the CDASH, SDTM and SDS teams of the CDISC Japan User Group (CJUG). He promotes the application of Clinical Data Acquisition Standards Harmonization (CDASH) of CDISC to define data items in case report forms (CRF) and registries.
Aimee Wang is senior project manager in clinical trial data management at MSD R&D (China) Co. Ltd. Aimee has been working in pharma industry for more than 9 years. She is very experienced on project management of clinical trial data management and very strong E2E data management knowledge for various therapeutic areas, including CRF design, database programming/testing, data cleaning, DBL and reporting, etc.
John Wang is Associate Director, Statistical Analysis, at dMed Biopharmaceutical Co., Ltd. He has 10+ years extensive statistical analysis experience in all phases of clinical trials, is familiar with different kinds of programming languages and system tools in clinical research. Before he joined dMed, he was Manager of SAS Programming at Johnson & Johnson China since 2009. Prior to that, he was associate manager of SAS programming for four years at Global Research Services, LLC. He is Vice Chair and team lead for the SDTM group in C3C (China CDISC Coordinating Committee). He has very extensive experience using CDISC fundamental data standards such as CDASH, SDTM, ADaM, Controlled Terminology and define.xml. He became a CDISC authorized SDTM Instructor in early 2016.
Stanley Wei is Group Head of Cardio-Metabolism Franchise in Statistical Reporting at Novartis Pharmaceutical. He is also currently undertaking a role in tools development in the Technology Standards and Processes group.
Stanley graduated from School of Pharmacy, Fudan University in 2006, with a Master’s degree in pharmacology and has more than 10 years of industrial experience in data manipulation, reporting and analysis, including 6+ years of CDISC standards implementation with clinical trial data (SDTM, ADaM and Define.XML) and 4 years of analysis with real-world observational databases (including US claims database, UK GPRD, IMS database, etc.). Prior to joining Novartis, Stanley also worked in PPD and Medifacts International for about 4 years as a programming manager.
Stanley is also one of the core and initial C3C (China CDISC Coordinating Committee) members, and has been responsible for the coordination of the CDISC China authorized trainer program, public training events, and is also the webmaster of the C3C official website for multiple years. In addition, he also coordinated and participated in the review process of the translated Chinese version of CDISC standards.
Victor Wu, Ph.D., is Co-founder of Beijing Data Science Express Consulting Co., Ltd. Dr. Wu has over 10 years of work experience in biometrics and 8 years of experience on CDISC standards implementation (including CDASH, SDTM and ADaM). He is highly proficient in clinical study, from protocol/statistical design, CRF development, SDTM mapping, programming for analysis datasets and tables, listings, figures to submission package. Victor is also experienced in process optimization. Victor has contributed to the review of the Chinese version of CDISC standards documents and has coordinated CDISC activities in China as vice chair & chair of C3C.
Hiromi Yamamoto is a reviewer of Advanced Review with Electronic Data Promotion Group at Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. She is a Certified Clinical Data Manager (CCDM) from the Society for Clinical Data Management (SCDM), and she has 12 years of data management experience at Eli Lilly. She is highly competent in all aspects of data management, across all phases of clinical trial research and in many therapeutic areas. Prior to this, she worked in clinical research operations at Eli Lilly, is a licensed pharmacist in Japan, and holds a Master degree in Pharmacy from Kyushu University and MBA. She will provide CDISC licensed training within PMDA only.
Seiko Yamazaki is a statistical analyst and a programmer at CMIC. Seiko obtained her master’s degrees in applied statistics and clinical psychology. She has been working on projects that require compliance with the CDISC standards. She is also active in implementing the ADaM standard in her role at CMIC. Her current job responsibilities include creating statistical analysis plans/mock-up plans, specs for analysis datasets, and creating tables, figures and listings.
Lily Zhao is Senior Director of Global Data Operations at PAREXEL. Lily holds a medical degree, and has been in the clinical research industry for 14 years after her 3-year career as a physician. She has rich project experience for both data management and project leadership in various therapeutic areas and has been using CDASH for CRF design and Dataset setup since 2008. She is actively involved in the CDISC standard-relevant activities in China, which include user group meetings, trainings, and CDASH standard translations. Lily formally became a member of C3C (China CDISC Coordinating Committee) in 2014.