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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.

Greater Clarity Starts with CDISC Education. We invite you to join us at one of our training events. You can also reach out to us with any questions you may have.


Kiyomi Ando

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.


Course(s) Taught:
CDASH Implementation

Training Language(s):
Japanese
Conversant Language(s):


Yoshihiro Aoyagi

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.


Course(s) Taught:
CDASH Implementation

Training Language(s):
Japanese
Conversant Language(s):


Dehong Cao

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.
 


Course(s) Taught:
SDTM Theory and Application

Training Language(s):
Chinese
Conversant Language(s):


Yanli Chang

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.


Course(s) Taught:
ADaM Primer
ADaM Theory and Application

Training Language(s):
Chinese
Conversant Language(s):


Yoshiteru Chiba

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.


Course(s) Taught:
CDISC for Newcomers
Define-XML
ODM Implementation
SDTM Theory and Application

Training Language(s):
Japanese
Conversant Language(s):


Kunihito Ebi

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.


Course(s) Taught:
Define-XML
ODM Implementation

Training Language(s):
Japanese
Conversant Language(s):


Masaaki Imasho

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.


Course(s) Taught:
CDASH Implementation
SDTM Theory and Application

Training Language(s):
English, Japanese
Conversant Language(s):


Kumiko Kimura

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.


Course(s) Taught:
ADaM Primer
ADaM Theory and Application

Training Language(s):
Japanese
Conversant Language(s):
English

Ruiling Peng

Ruiling Peng is the Vice President of the CDISC C3C, and the CEO of Beijing Improve-Quality Tech. Co., Ltd., which was the first company in China to obtain CDISC membership. Ruiling joined the CDISC China Coordinating Committee (C3C) in 2012 and has worked to organize seminars and user group meetings from which more than 2,500 attendees have benefited. Ruiling joined the CDISC TCM project team in 2014 and supported the TCM model publishing in December 2018. Ruiling began working in clinical trials in 2006 where she worked for Pfizer and Novo Nordisk for a combined 10 years. Prior to 2006, Ruiling worked at the Peking University School of Public Health as a lecturer and researcher for 5 years. She obtained her master’s degree from Peking University in 2001.


Course(s) Taught:
Define-XML
ODM Implementation

Training Language(s):
Chinese
Conversant Language(s):


Taku Shimizu

Taku Shimizu is currently a Statistical Programmer at IQVIA Services Japan K.K. He has been a SDTM specialist for 8 years with practical experience of SDTM development (50+ protocols) and implementation with multiple pharmaceutical companies. He has managed all aspects of the SDTM, including define.xml and SDRG, development and operation processes (schedules, designs, productions, tests, releases, modifications 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 BSc in Biochemistry from the Kyoto Institute of Technology.


Course(s) Taught:
SDTM Theory and Application

Training Language(s):
Japanese
Conversant Language(s):
English

Akira Soma

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.


Course(s) Taught:
SDTM Theory and Application

Training Language(s):
Japanese
Conversant Language(s):


Satoshi Ueno

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.
 


Course(s) Taught:
CDASH Implementation

Training Language(s):
Japanese
Conversant Language(s):


Aimee Wang

Aimee Wang is Associate Director of Clinical Data Management at IQVIA. Aimee has 10+ years DM experience in all phases of clinical trials. She is very experienced for both E2E data management activities and project leadership in various therapeutic areas. She has been using CDISC standards for several years and is involved in the CDASH standard-relevant activities in China.


Course(s) Taught:
CDASH Implementation

Training Language(s):
Chinese
Conversant Language(s):
English

John Wang

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.


Course(s) Taught:
CDISC for Newcomers
SDTM Theory and Application

Training Language(s):
Chinese
Conversant Language(s):
English

Zhijun Wei

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.


Course(s) Taught:
SDTM Theory and Application

Training Language(s):
Chinese
Conversant Language(s):
English

Chongsheng (Victor) Wu

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.


Course(s) Taught:
ADaM Primer
ADaM Theory and Application
SDTM Theory and Application

Training Language(s):
Chinese
Conversant Language(s):
English

Anran Xie

Anran Xie is the Director of Data Management at Beijing Improve-Quality Tech. Co., Ltd., which was the first company in China to obtain a CDISC membership. Anran started working with CDISC standards in 2012 and started working on the ODM and Define-XML translation project in 2013. Anran began working in clinical trials in 2006 where he worked with global pharmaceutical companies Pfizer, Novo Nordisk, and AstraZeneca. In 2005, Anran received a Bachelor’s Degree in Clinical Medicine from Jiaotong University.


Course(s) Taught:
Define-XML
ODM Implementation

Training Language(s):
Chinese
Conversant Language(s):


Seiko Yamazaki

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.


Course(s) Taught:
ADaM Primer
ADaM Theory and Application

Training Language(s):
English, Japanese
Conversant Language(s):


Lily Zhao

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.


Course(s) Taught:
CDASH Implementation

Training Language(s):
Chinese
Conversant Language(s):
English