Authorized Instructors

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 contact us with any questions you may have.

Authorized Instructor Form

Jozef Aerts

Jozef Aerts is professor in Medical Informatics at the University of Applied Science FH Joanneum in Graz, Austria. He has been an active CDISC volunteer since 2002, is one of the main developers of the ODM and SDM-XML standards, and has contributed to other standards and CDISC documents such as define.xml and the Metadata Submission Guide.

Jozef is also owner and CEO of XML4Pharma, a software development and consultancy company specializing in implementation of CDISC standards and well-known for its ODM and define.xml editing, viewing and checking tools, and for its ODM to SDTM mapping software.

In his sparse free time, Jozef likes to climb mountains in the Alps. He is also a mountaineering instructor for the German Alpine Club (DAV).

Course(s) Taught:
Define-XML, ODM Implementation

Training Language(s):
Dutch, English, German
Conversant Language(s):
French

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 Fundamentals and Implementation

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


Nancy Brucken

Nancy Brucken is a Standards Engineer on the Data Standards team at IQVIA, responsible for ADaM implementation, compliance and internal tool development. She has been an ADaM team member since 2011, a contributor to the OCCDS v1.0, Rheumatoid Arthritis Therapeutic Area, ADaM IG v1.2, ADaM COVID-19 guidance, ADaM Metadata Submission Guidelines and Traceability sub-teams, serves as co-leader of the ADQRS sub-team, and received a CDISC award for Outstanding Contributions to Standards Development in 2017. Nancy has been a frequent presenter and seminar/workshop instructor on ADaM-related topics at various industry conferences.

Course(s) Taught:
ADaM Advanced, ADaM Core Theory and Application, CDISC for Newcomers

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

Dehong Cao

Dehong Cao is the Head of Clinical Data Management of Luoxin Pharmaceutical. Previously he worked at eClinwise Data Science as Vice president of DM & Programming, and worked at MSD China as Associate Director of SDTM Mapping & Clinical Data Reporting. He has 10+ years extensive experience in Clinical Data Management, 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 Changes and Updates, SDTM Theory and Application

Training Language(s):
Chinese - Mandarin
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 Core Theory and Application

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


Yoshiteru Chiba

Yoshiteru Chiba is a Visiting Researcher in the Department of Health Communication of the Division of Epidemiology and Health Science, School of Public Health, Graduate School of Medicine, the University of Tokyo since 2019. 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. He has been the CDISC Liaison in Japan since 2019-2021.

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

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


Nick De Donder

Nick De Donder graduated as a biomedical scientist from the University of Ghent, Belgium in 2007 and since 2008 has been employed by Business & Decision Life Sciences at their headquarters in Brussels. He started off in the CRO as a Data Integration Specialist, with responsibilities for the creation of SDTM annotated CRFs, defining the mapping of the conversion process to produce SDTM datasets based on legacy data, the creation of the Define-XML and the complete quality process. Over the years he held different job titles like Project Manager, Line Manager and is now the Head of Data Standards, where he is responsible for the overall quality of the projects and helps defining data standards processes for the industry. Nick is a member of the SDS team for the development of the new standards and a PHUSE committee member since 2017. He is currently leading the European CDISC Coordinating Committee (E3C).

Course(s) Taught:
CDISC for Newcomers, SDTM Advanced, SDTM Changes and Updates, SDTM Theory and Application

Training Language(s):
Dutch, English
Conversant Language(s):
French

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):


Gitte Frausing

Gitte Frausing is Principal Consultant in Data Standards Decisions where she is working with companies implementing CDISC standards across the world. With her background in toxicology, she specializes in nonclinical and laboratory data with unique insight in the end-to-end data flow processes and brings this rare perspective and expertise to every client.

 

Gitte is a long-standing member of the CDISC SEND team. She has lead several efforts as a sub-team leader within the SEND team and has contributed to a substantial part of version 3.0 of the SEND Implementation guide as well as the next release (version 3.1).

Course(s) Taught:
SEND Implementation

Training Language(s):
Danish, English
Conversant Language(s):
French, Swedish

Nate Freimark

Nate Freimark is Vice President - Clinical Programming and Data Standards at The Griesser Group. He served as ADaM team lead from 2010-2017, and is a member of the CDISC GGG (Global Governance Group), SDS Oncology, QS and Compliance sub-teams. Nate is also a member of several PHUSE teams (working on improving data quality and site selection standards) and the ADaM lead on the development for many Therapeutic Area User Guides (TAUGs). He has been a member of the ADaM team since 2005, a member of the ADaM Leadership Team since its creation, and has been “doing CDISC” since 2004. Nate has been involved in ADaM Education since its inception from the development of the training material to giving public, private, and FDA ADaM training courses.

Nate is also a lead programmer who has worked on numerous projects involving the creation of SDTM and ADaM datasets (and associated defines) as well as the tables, listings, and graphs created based upon them dating back to 2004. He works closely with other project team members within The Griesser Group and outside of The Griesser Group to produce a quality product on time. He has extensive experience with a broad range of therapeutic areas including anti-infective, oncology, and pain management studies.

Nate has also been a liaison between integrating companies trying to figure out how best to move forward in a unified CDISC-compliant environment.

Course(s) Taught:
ADaM Advanced, ADaM Core Theory and Application

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

Marcelina Hungria

Marcelina has owned the CDISC/SAS Consulting Services company DIcore Group for 11 years, focusing on Metadata Repository (MDR) development, CDISC Standards Implementation and Data Submission Preparation and Validation. She has over 29 years’ experience working as an information technology consultant for multiple companies and standards development organizations. Marcelina has 15 years’ experience serving as a CDISC ODM, Define-XML, and SDTM/SDTMIG Volunteer.

Course(s) Taught:
Define-XML

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

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 Fundamentals and Implementation , SDTM Theory and Application

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


Monika Kawohl

Monika Kawohl is a Principal Statistical Programmer at mainanalytics in Germany and has 25 years of experience in the pharmaceutical industry. Her daily work includes the hands-on application of CDISC standards towards e-submission as well as consulting clients regarding their implementation of SDTM, ADaM and Define-XML. Monika joined the ADaM team in 2009 and has served as a CDISC authorized ADaM Instructor since 2012. Through work on the ADaM metadata sub-team she also became involved with the CDISC Define-XML team and as a consequence, the Define-XML course as well as the CDISC for Newcomers course have been added recently to her CDISC classes taught list. Additionally, Monika is a member of the executive committee of the German-speaking CDISC User Network.

Course(s) Taught:
ADaM Advanced, ADaM Core Theory and Application, CDISC for Newcomers, Define-XML

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


Éanna Kiely

Éanna Kiely is the Head of Clinical Data Standards team in UCB which is responsible for defining and implementing CDASH and SDTM standards. He leads data collection in the End to End Standards Teams. He supports on MDR implementation, standards ontology creation and RWD submissions.

He is a CDISC Consultant through ClinBuild where he provides CDISC standards implementation and governance services and trainings. He also lectures on CDISC standards. He is an Authorized CDASH Instructor and SDTM and CT Instructor in Training. He has been an active CDISC volunteer since 2013 as a member of the SDS (SDTM), CDASH and Laboratory teams.

He is an author on  CDASHIG 2.0 and Model 1.0, SDTMIG 3.3 and 3.4 and the Malaria TAUG V1.0. He is currently the lead of the SDS Lab Units Representation team and co-lead of the Protocol Deviations team. He is a member of the European CDISC Coordinating Committee where he helps organize the European Interchange and represents CDISC in Europe. He frequently presents on CDISC topics.

Course(s) Taught:
CDASH Fundamentals and Implementation

Training Language(s):
English
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 Core Theory and Application

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

Erin Muhlbradt

Dr. Erin Muhlbradt is a contractor for the US National Cancer Institute’s Enterprise Vocabulary Services (NCI EVS) and is the NCI EVS and CDISC project lead for CDISC terminology development. Dr. Muhlbradt has over 10 years’ experience in the bioinformatics and pharmaceutical industries, with skills including terminology development, standards development, database and metadata repository development, and data modeling.

She manages a team at EVS that is responsible for the development, publication, and maintenance of CDISC controlled vocabularies in use by the pharmaceutical industry and mandated by the US Food and Drug Administration (FDA) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Her duties include project management, biomedical and clinical subject matter expertise, terminology development, quarterly terminology publications, and management of the CDISC terminology change request mechanism. Previously, Erin was a doctoral candidate at Georgetown University in the Tumor Biology department and she performed her thesis work in prostate cancer cell signaling in laboratories at Georgetown University (Washington, DC) and Columbia University (New York, NY).

Erin holds a Bachelor of Science Degree (Honors) in Molecular and Cellular Biology from the University of Glasgow (Glasgow, Scotland) and a Doctoral Degree in Tumor Biology from Georgetown University (Washington, DC).

Erin leads, co-leads, or oversees 19 active CDISC controlled terminology teams. She is a co-lead of the SDS PGx subteam, a co-lead of the SDS Cell Phenotyping sub-team, a voting member of the CDISC Global Governance Group (GGG), and a terminology representative on many active therapeutic area standards development teams.

Course(s) Taught:
Controlled Terminology, Controlled Terminology Advanced

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


Lisa Mulcahy

Lisa Mulcahy has an extensive career in the biopharmaceutical industry in the areas of Clinical Operations, Quality Management, and TMF Management. She became an independent consultant 16 years ago, tying previous work experiences together to assist clients to develop, revise, and operationalize high-quality and compliant TMF management processes to achieve complete and inspection-ready of TMFs. Her consultancy allows her the pleasure to work with clients, very small biotechs to large pharmaceutical companies, in many different ways, such as selection, implementation, and expanded use of eTMF systems, training and/or leading TMF management resources, performing quality and completeness reviews of study-specific TMFs, and performing a company’s TMF management assessments for clients so they can establish and/or improve processes to become more compliance and inspection ready. Each of her projects with the focused intent to achieve compliant, complete, and inspection-ready TMFs. Lisa is a co-founder and a current Steering Committee member of the CDISC TMF Reference Model volunteer team of industry representatives that created and maintain the model.

Course(s) Taught:
Fundamentals of the TMF Reference Model

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

Dawn Niccum

 

With over 30 years of Clinical Operations, Clinical Systems and Quality Assurance pharmaceutical experience, Dawn provides our clients a unique perspective of efficiency, speed, and compliance. She is an experienced leader in clinical compliance and auditing, inspection readiness activities, SOP development, computer system validation, quality document management, training, and safety. Her extensive experience and strength in establishing quality structures and streamlined approaches to reduce risk remains a tremendous asset in inSeption’s ability to deliver outstanding quality, best practices, efficient systems, and cost savings to our sponsors. Additionally, Dawn is recognized for her expertise in implementing TMFs across settings and systems, is a member of the CDISC TMF Reference Model Group Steering Committee and Chair of the Education Committee, is an active member of the Society of Quality Assurance and has presented as a Subject Matter Expert at numerous conferences.

Course(s) Taught:
Fundamentals of the TMF Reference Model

Training Language(s):
English
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 - Mandarin
Conversant Language(s):


Soumya Rajesh

Soumya Rajesh has 18+ years of experience in the areas of SDTM Standards, Programming and Regulatory Operations, in various Therapeutic Areas and study phases. Previous publications cover topics such as Clinical Classifications, Findings About, Disposition, SDTM IG vs. Model, and ISS & ISE Dataset Preparation, at various industry conferences since 2018. Soumya is also the Lead for the CDISC SDS LT, Co-Lead of the SDS NSV sub-team, is an authorized CDISC instructor, member of CDASH NSV Registry sub-team, PHUSE Working Groups, and PharmaSUG Conference Committee. :+1: 1

Course(s) Taught:
CDISC for Newcomers, SDTM Advanced, SDTM Changes and Updates, SDTM Theory and Application

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

Jerry Salyers

Jerry is currently SDTM and CDASH Implementation Advisor for Data Standards Consulting, a Talent Mine Group. Jerry previously worked for the Accenture Life Sciences Data Standards Consulting group starting in January 2009 after 15 years in clinical data management at Procter and Gamble Pharmaceuticals.  During his time with P&G, Jerry was involved in getting several new drugs and indications through the clinical-trial process and ultimate submission.  He presented at numerous investigator meetings across the US and throughout Europe.  With P&G, he was also active within the industry, representing P&G at the e-Clinical Forum (in both the US and Europe), where he presented a number of papers on electronic data capture and data warehousing.

 

With Accenture, Jerry provided internal consulting resources to the Data Standards and Integration department as well as the in-house data management group.  He also worked one-on-one directly with several sponsors in review of mapping specifications (via CRFs and datasets) from source to SDTM-based datasets.

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

Training Language(s):
English
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 10 years with practical experience of SDTM development (60+ protocols) and implementation with multiple pharmaceutical companies. He has managed all aspects of the SDTM, including define.xml, SDRG, and Attachment 8 for PMDA, 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

Jack Shostak

Jack Shostak manages a group of statistical programmers and is an Associate Director of Statistics at the Duke Clinical Research Institute.  He is the author of SAS Programming in the Pharmaceutical Industry and coauthor of Common Statistical Methods for Clinical Research with SAS Examples, Third Edition as well as Implementing CDISC Using SAS: An End-to-End Guide, Second Edition. Jack has been active in CDISC since 2002 primarily as a contributor to ADaM model development.  Jack serves as a member of the ADaM leadership team and has been a CDISC ADaM instructor for industry and the FDA for the past decade.

Course(s) Taught:
ADaM Core Theory and Application

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


Akira Soma

Akira Soma is a Master principal solution consultant at Oracle Health Sciences Global Business Unit with over seven 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 the chair of Japan CDISC Coordinating Committee (J3C) since 2021, involved with the Japan CDISC User Group SDTM team for more than 10 years, and had been active in a couple of PhUSE CSS Working Groups.

Course(s) Taught:
SDTM Theory and Application

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


Angelo Tinazzi

Angelo has more than 20 years' experience in the field of Clinical Research in the areas of Data Management and Statistical Programming, serving different roles at Academic Organizations, CROs and Pharmaceutical Industries in Italy, Switzerland and the UK.

Since 2003, the application of CDISC standards in different therapeutic areas has been part of his core expertise, particularly in the context of data submission to regulatory authorities, such as the FDA and PMDA. Angelo is a member of the CDISC ADaM Team as well as the CDISC European Coordinating Committee where he is responsible for the Italian-speaking User Network.

Angelo is Italian, living in France and working in Geneva, Switzerland as Senior Director of Standards, Systems, CDISC Consulting in the Statistical Programming group of Cytel, Inc.
 

Course(s) Taught:
ADaM Advanced, ADaM Core Theory and Application

Training Language(s):
English, Italian
Conversant Language(s):
French

Johannes Ulander

Johannes is a Principal Consultant at S-Cubed focusing on standardization and standards governance, helping clients to create sustainable CDISC deliverables. Before joining S-Cubed he was the SDTM Development Team Lead, leading a global team of SDTM experts in the AstraZeneca standards organization. The work included governing, developing and implementing SDTM standards within the company, as well as contributing to other standards development internally to have an end-to-end alignment when moving towards more CDISC adaption. He is a member of the CDISC Definitions Team and the E3C.

Course(s) Taught:
SDTM Theory and Application

Training Language(s):
English, Swedish
Conversant Language(s):
Danish

Gary Walker

Gary Walker has worked in the pharmaceutical industry since 1992 and tells people his career path took the proverbial "scenic route."  He started in IT and moved to Research and Development IT, supporting CANDA (Computer Assisted New Drug Applications) submissions. He subsequently moved to Regulatory Affairs and Publishing where Gary helped to create numerous marketing applications and supplements in electronic format from 1997 through 2005. In 2001, while working in regulatory, Gary became a member of the CDISC SDS team.  In 2005 Gary moved from regulatory to Data Standards within Quintiles’ Global Data Management department.   In this role, Gary supported CDISC standards for data preparation within Data Management and Biostatistics, both for submission using SDTM and in the data collection and cleaning processes of Data Management, through the adoption of SDTM-friendly variables and the use of SDTM naming fragments for non-standard variables.  Gary joined the CDASH initiative in 2006 and led the Demographics domain team for version 1.0.  Gary continues to actively participate on the work on many of the CDISC standards including SDTM, CDASH and CDISC Library. Prior to leaving Quintiles (now IQVIA), Gary worked within the Innovation group which was focused on new and innovative products, and was part of a team focused on EHR data use for clinical research.

Course(s) Taught:
CDASH Advanced, CDASH Fundamentals and Implementation , CDISC for Newcomers, SDTM Advanced, SDTM Changes and Updates, SDTM Theory and Application

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


John Wang

John Wang is Senior Director, Statistical Analysis, at dMed Biopharmaceutical Co., Ltd. He has 14+ 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 - Mandarin
Conversant Language(s):
English

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 Fundamentals and Implementation

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

Richann Watson

Richann Watson is an independent statistical programmer and CDISC consultant with over 20 years’ experience working in the pharmaceutical industry. She is a member of the ADaM team. She contributed to ADaMIG v1.2. In addition, Richann is a member of the ADaM Oncology and the ADaM Traceability sub-teams. She is an Executive Committee member for PharmaSUG, WUSS and SESUG. Richann has presented several papers and seminars on ADaM-related topics at various conferences.

Course(s) Taught:
ADaM Advanced, ADaM Core Theory and Application

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

Zhijun Wei

Stanley Wei is Group Head of Data Management and Innovation 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 - Mandarin
Conversant Language(s):
English

Mario Widel

Mario Widel is a statistical programmer at Reata Pharmaceuticals Inc. He has been doing statistical programming since 1992. He has been involved in CDISC related activities since 2007 on a previous company having a key role in the transition to CDISC standards CDASH, SDTM and ADaM. In his current role, Mario oversees and reviews submission deliverables including aCRF, SDTM, ADaM and define.xml.

He received his M.S. degree in Computer Science from the University of Illinois at Chicago. He is a regular presenter at conferences like JSM, PharmaSUG, SAS Global Forum, PhUSE and CDISC and a member of ASA and the CDISC ADaM team.

Course(s) Taught:
ADaM Advanced, ADaM Core Theory and Application, SDTM Theory and Application

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


Fred Wood

Fred Wood has been active in leading the development of CDISC standards since 1999. He is one of the principal contributors to the CDISC Study Data Tabulation Model (SDTM), and is a founding member of the SDS Team (1999) and the SEND Team (2002); he led or co-led both teams for many years. Fred created the first SEND domains in 2002. 

Fred has been an independent consultant since 2021. Prior to that, he had a number of management roles in various companies, including Vice President for Consulting Services at TalentMine (2018-2020), lead for the Data Standards Consulting Group within Accenture's Accelerated R&D Services (2006-2017), and Global Data Standards Manager for Procter & Gamble Pharmaceuticals (1998-2006). Fred has a Ph.D. and an M.S. from the University of Massachusetts in Amherst, and a B.S. from Springfield College in Springfield, Massachusetts.

Course(s) Taught:
SEND Implementation

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


Chongsheng (Victor) Wu

Victor Wu, Ph.D., is Co-founder of Beijing Data Science Express Consulting Co., Ltd. Dr. Wu has over 15 years of work experience in biometrics and 13 years of experience on CDISC standards implementation (including CDASH, SDTM and ADaM) and submission package preparation to multiple agencies . He is highly proficient in clinical study, from protocol/statistical design, CRF development, programming for transformed/analysis datasets, to TFLs/report. Victor is also experienced in process optimization and tools development. Victor has contributed a lot to lead the Chinese translation of CDISC standards documents and to coordinate CDISC activities in China as chair of C3C.

Course(s) Taught:
ADaM Core Theory and Application, CDISC for Newcomers, SDTM Changes and Updates, SDTM Theory and Application

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


Seiko Yamazaki

Seiko Yamazaki is a CDISC consultant at Pinnacle 21 and has been working in the pharmaceutical industry since 2012. Before joining Pinnacle 21, she was a statistician at CMIC and worked on a diverse array of projects that require compliance with CDSIC standards. She possesses significant experience creating analysis plans/mock-up plans, ADaM specs, ADaM datasets, tables, figures, and listings. Seiko holds master’s degrees in applied statistics and clinical psychology.

Course(s) Taught:
ADaM Core Theory and Application

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


Lily Zhao

Lily Zhao is the Vice President of Data Management and Pharmacovigilance at Innovent Biologics Inc. Lily holds a medical degree, and has been in the clinical research industry for 17 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 Fundamentals and Implementation

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