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.
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 ImplementationTraining Language(s):
Dutch, English, GermanConversant Language(s):
FrenchYoshihiro Aoyagi
Yoshihiro Aoyagi is the manager of the Department of medical information at the National Cancer Hospital East in Japan. His main areas of expertise include project management, data management, clinical trials digital transformation. He has taken an essential role in developing various information systems such as remote SDV and direct data capture from EMR to improve the utilization of information resources in the hospital. He has also researched the use of Hospital Information System data and improved its reliability and transparency. He has been an authorized instructor for the CDISC CDASH and a global collaborator for the OHDSI. He used to work as a clinical pharmacist specializing in drug information.
Course(s) Taught:
CDASH Fundamentals and ImplementationTraining Language(s):
JapaneseConversant Language(s):
Nancy Brucken
Nancy Brucken is a Senior 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 NewcomersTraining Language(s):
EnglishConversant Language(s):
EnglishBhavin Busa
Bhavin Busa is the Principal and Co-founder of Clymb Clinical, and a thought leader in the areas of data standards, programming, and regulatory submissions. As the CDISC Analysis Results Standard (ARS) Product Owner and Co-lead, he has played a pivotal role in developing this foundational standard, which promises to enhance automation across the clinical data lifecycle. Bhavin also serves on the PHUSE Working Group Leadership Committee and the CDISC Open-Source Alliance (COSA) Board and was the Chair of PHUSE US Connect 2024.
With his visionary perspective, Bhavin sees CDISC ARS as a key enabler of automation, supporting not only TFL generation but also ADaM, SDTM, CRF, and downstream processes like AI-driven Statistical Report and CSR production. His innovative approach drives Clymb Clinical's automation solutions, solidifying the company's leadership in transforming clinical data science.
Course(s) Taught:
ARS Hands-On Implementation TrainingTraining Language(s):
EnglishConversant Language(s):
EnglishDehong 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 ApplicationTraining Language(s):
Chinese - MandarinConversant 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 ApplicationTraining Language(s):
Chinese - MandarinConversant 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 ApplicationTraining Language(s):
JapaneseConversant Language(s):
Nick De Donder
Nick De Donder graduated as a biomedical scientist from the University of Ghent, Belgium in 2007 and has been employed since 2008 by Business & Decision Life Sciences at their headquarters in Brussels. He has been moving from being a Data Integration Specialist to Project Manager to Line Manager for the Data Standards team. Since 2020 he is Head of Data Standards. Nick is a member of the SDS team, an authorized CDISC trainer for CDASH, SDTM and Newcomers and a PHUSE committee member since 2017. In 2019 he joined the E3C and is now co-chairing it. Since June 2021 Nick has been product owner of the CORE application.
Course(s) Taught:
CDASH Advanced, CDASH Fundamentals and Implementation , CDISC for Newcomers, SDTM Advanced, SDTM Changes and Updates, SDTM Theory and ApplicationTraining Language(s):
Dutch, EnglishConversant Language(s):
FrenchKunihito 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 ImplementationTraining Language(s):
JapaneseConversant 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 ImplementationTraining Language(s):
Danish, EnglishConversant Language(s):
French, SwedishNate 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 ApplicationTraining Language(s):
EnglishConversant Language(s):
HebrewMarcelina 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:
CDISC for Newcomers, Dataset-JSON Hands-on Implementation , Define-XML, ODM ImplementationTraining Language(s):
English, SpanishConversant Language(s):
English, SpanishMasaaki 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 ApplicationTraining Language(s):
English, JapaneseConversant Language(s):
Els Janssens
Els Janssens has more than 12 years of experience in the field of Clinical Data Management and started at SGS Health Science in 2012. After gaining experience in pharma overseeing DM CRO activities, she returned to SGS as DM Data Standards and Process Manager responsible for maintaining the CDISC SDTM standards. In her current role as Data Management System and Process Manager, she is a DM expert and point of contact concerning DM systems and processes, with her primary focus on data standards and regulatory requirements. She is also part of the PHUSE EU Connect Committee, member of the CDISC E3C, and CDISC Open Rules volunteer since September 2021. Els holds a master’s degree in Industrial Sciences: Biochemistry, a master's degree in Cellular Biotechnology and a PhD in Biomedical Sciences.
Course(s) Taught:
CDISC Open Rules Hands-on Implementation TrainingTraining Language(s):
EnglishConversant Language(s):
EnglishMonika 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-XMLTraining Language(s):
English, GermanConversant 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 ImplementationTraining Language(s):
EnglishConversant 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 ApplicationTraining Language(s):
JapaneseConversant Language(s):
EnglishErin 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 15 years’ experience in the bioinformatics and pharmaceutical industries, with skills including terminology development, data 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, biannual terminology publications, and management of the CDISC terminology change request mechanism.
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 Genomics subteam, a co-lead of the SDS Cell Phenotyping sub-team, a co-lead of the SDS Lab team, a voting member of the CDISC Global Governance Group (GGG), and a terminology representative on many therapeutic area standards development teams.
Course(s) Taught:
Controlled Terminology, Controlled Terminology AdvancedTraining Language(s):
EnglishConversant Language(s):
EnglishLisa 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, The Critical Role of Data Managers, Biostatisticians, and Programmers in Achieving TMF ExcellenceTraining Language(s):
EnglishConversant Language(s):
EnglishDawn 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, The Critical Role of Data Managers, Biostatisticians, and Programmers in Achieving TMF ExcellenceTraining Language(s):
EnglishConversant Language(s):
EnglishJunseok Park
Junseok Park serves as the Team Manager for Data Management at CMIC Korea. With a background in C&R Research's DM/IT team, he brings 8 years of expertise in managing clinical data and databases. Transitioning to a leadership role, he oversaw comprehensive data management responsibilities at CMIC Korea/C&R Research, which included the development of SOP and WI. Park holds certifications as a Certified Clinical Data Manager and CDISC Tabulate, along with being a Certified Advanced Programmer for SAS9, specializing in SDTM work. His professional journey spans over 14 years, encompassing diverse therapeutic areas across all phases of clinical trials.
Course(s) Taught:
SDTM Theory and ApplicationTraining Language(s):
KoreanConversant Language(s):
English, KoreanRuiling 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 ImplementationTraining Language(s):
Chinese - MandarinConversant Language(s):
Rajesh Saha
Rajesh has over 15 years of extensive expertise in Clinical Data Standards and Clinical Programming. He is currently the Clinical Programming Portfolio Lead at J&J. Wherein he is accountable for delivery of SDTM and DRM (Data Review Model) for his portfolios.
With a tenure of more than 5 years as a pivotal member of the Clinical Data Standards team at J&J, Rajesh maintains his status as a Standards Strategic Partner within the organization. His proficiency spans key areas of standards including CDASH, SDTM, Define.xml, ODM, and MDR solutions.
Rajesh's passion for teaching is evident through his longstanding role as a standards trainer within J&J. Additionally, he was appointed as an authorized trainer at CDISC in 2023, further underscoring his commitment to advancing industry standards and knowledge dissemination.
Course(s) Taught:
CDASH Fundamentals and Implementation , SDTM Advanced, SDTM Theory and ApplicationTraining Language(s):
EnglishConversant Language(s):
EnglishJerry 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 ApplicationTraining Language(s):
EnglishConversant Language(s):
Sandeep Sawant
Based in India, Sandeep plays a key role in the formation of the CDISC user group there. He is the winner of multiple academic honors and possesses a master's degree in statistics. He has worked in data standards, statistical programming, and biostatistics for about 20 years. He is currently an Associate Director of Data Standards and Governance at Syneos Health. He has given numerous trainings and workshops on SDTM and ADaM in a variety of industry forums in India and other countries. Several industry forums have published some of his most important contributions. In 2015–16, he finished his CDISC Fellowship, and he co-wrote CFAST TAUG, which treats breast, prostate, and malaria.
Course(s) Taught:
CDASH Fundamentals and Implementation , SDTM Theory and ApplicationTraining Language(s):
EnglishConversant Language(s):
EnglishTaku 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 ApplicationTraining Language(s):
JapaneseConversant Language(s):
EnglishJack Shostak
Jack Shostak is the Director of Biostatistical Operations 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 has been a CDISC ADaM instructor for industry and the FDA for the past decade.
Course(s) Taught:
ADaM Core Theory and ApplicationTraining Language(s):
EnglishConversant Language(s):
Akira Soma
Akira Soma is a Solution Director at Oracle Life Sciences with over nine years of experience in clinical development and pharmacovigilance. With a robust background spanning more than 15 years in the pharmaceutical industry across Japan and the United States, his expertise primarily lies in clinical data management and IT. Before joining Oracle, Akira was the Manager of Data Management/IT at Mitsubishi Tanabe Pharma Development America, where he was responsible for governing, developing Standard Operating Procedures (SOPs) and Work Instructions (WIs), and implementing Study Data Tabulation Model (SDTM) standards within the company. Akira has been serving as the Chair of the Japan CDISC Coordinating Committee (J3C) since 2021 and has been involved with the Japan CDISC User Group SDTM team for over a decade. Additionally, he has actively participated in several PhUSE Computational Science Symposium (CSS) Working Groups.
Course(s) Taught:
SDTM Theory and ApplicationTraining Language(s):
JapaneseConversant Language(s):
English, JapaneseAngelo Tinazzi
Angelo Tinazzi is Senior Director, Statistical Programming, Project Based Service (PBS), responsible for Clinical Data Standards and Data Submission, working at Cytel since 2012. Angelo has about 30 years’ of experience working with different organizations in Italy, UK, and Switzerland.
In his role at Cytel, Angelo lead data standards initiatives as well as advising clients and internal teams on best strategies for implementing data standards for submission with health authorities such as FDA, PMDA, and NMPA. He also supports applications development and automation initiatives for the Cytel PBS Statistical Programming Group.
Angelo is a CDISC ADaM Authorized Instructor and member of the CDISC European Coordinating Committee where he is also leading Italian speaking User Network.
Course(s) Taught:
ADaM Advanced, ADaM Core Theory and ApplicationTraining Language(s):
English, French, ItalianConversant Language(s):
English, French, ItalianJohannes Ulander
Johannes is a Partner at data4knowledge ApS, having more than 20 years of experience in standardizing and governing clinical data standards and terminology.
He has lead multiple SDTM Development Teams and been managing standards implementations from an end-2-end perspective at large pharma companies. He also has expertise automating the clinical data flow with linked data and graph databases, enabling the use of other CDISC standards such as Biomedical Concepts and USDM. Frequently speaking at CDISC and Phuse conferences on novel ways of working.
He has been member of the CDISC SDS and CDISC Definitions Team, and currently a member of the CDISC E3C team.
Course(s) Taught:
SDTM Theory and ApplicationTraining Language(s):
English, SwedishConversant Language(s):
DanishGary 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 ApplicationTraining Language(s):
EnglishConversant 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 ApplicationTraining Language(s):
Chinese - MandarinConversant Language(s):
EnglishAimee Wang
Aimee Wang is Director of Clinical Data Management at IQVIA. Aimee has 16+ 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 ImplementationTraining Language(s):
Chinese - MandarinConversant Language(s):
EnglishRichann Watson
Richann Watson is an independent statistical programmer and CDISC consultant with over 25 years’ experience working in the pharmaceutical industry. She is a member of the ADaM team. She contributed to ADaMIG v1.2 as well as the ADaM Oncology and ADaM Traceability supporting documents. In addition, Richann is a member of the ADaM v3.0 sub-team. She is an Executive Committee member for PharmaSUG and WUSS. Richann has presented several papers and seminars on ADaM-related topics at various conferences.
Course(s) Taught:
ADaM Advanced, ADaM Core Theory and ApplicationTraining Language(s):
EnglishConversant Language(s):
EnglishZhijun 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 ApplicationTraining Language(s):
Chinese - MandarinConversant Language(s):
EnglishMario Widel
Mario Widel is an ADaM Standards Engineer at IQVIA. 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 develops and maintains ADaM standards and submission deliverables.
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 ApplicationTraining Language(s):
English, SpanishConversant Language(s):
English, SpanishFred 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 ImplementationTraining Language(s):
EnglishConversant 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 ApplicationTraining Language(s):
Chinese - MandarinConversant Language(s):
EnglishAnran 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 ImplementationTraining Language(s):
Chinese - MandarinConversant 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 ApplicationTraining Language(s):
English, JapaneseConversant 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.