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.
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).
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.
Anne-Sophie Bekx started her career in the pharmaceutical industry in 2009 after obtaining a master’s degree in Biomedical Sciences from the Université Libre de Bruxelles. She currently works at Janssen Pharmaceutica as an Associate Director, Technical Data Architect Lead, managing a team of technical data managers working on late development oncology trials, post-submission trials and real-world evidence.
Prior to that she worked as the Line Manager for the Data Standards team at the CRO Business & Decision Life Sciences (BDLS). In this role she was responsible for the operational management of the project teams and personnel working within the CDISC Data Standards & Implementation department of the BDLS CRO. This team works to create CDISC compliant data standards libraries (CDASH, SDTM, ADaM and SEND) as well as CDISC-compliant, submission-ready packages for FDA and PMDA submissions.
She has been an authorized CDISC SDTM and CDASH trainer since January 2016 and is the PHUSE EU CONNECT 2020 Conference Chair.
Having worked for more than 15 years within the different areas of clinical data flow ranging from collection to statistical analysis and submission, Niels Both provides training in CDISC standards, coupled with a unique understanding of the everyday problems encountered when submitting data in SDTM, define.xml or ADaM to FDA.
For the last 4 years, Niels has been working as Principal consultant for S-cubed, assisting companies across Europe implementing CDISC standards e2e ranging from CDASH over SDTM to ADaM.
Niels has been active in the CDISC community for almost 10 years, presenting CDISC at road-shows, conferences and other events.
Nancy Brucken is a Standards Engineer on the Data Standards team at Clinical Solutions Group, Inc., 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 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.
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.
Sally Cassells serves on CDISC’s Data Science Team as Senior Director of Data Exchange Standards. She leads the development of Data Exchange Standards and participates in work on CDISC Library. As a founding member of the Data Exchange Standards team, Sally contributed to the development of ODM and Define-XML from inception to current versions. Prior to joining CDISC, she provided technical consulting services for organizations implementing CDISC Data Exchange standards and spent over 25 years developing clinical research and drug safety software products at BBN Software, Belmont Research, Lincoln Technologies, Phase Forward and Oracle.
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.
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 first worked 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. After a couple of years he became a Project Manager for conversion projects. After eight years, he became Line Manager for the Data Standards team, where he is responsible for the overall management of the team, ensuring the continuity and training of new staff. Nick is a member of the SDS team for the development of the new standards and a PhUSE committee member since 2017 and is currently the E3C Chair.
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.
Gitte Frausing is the CEO and 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 the SEND Implementation guides as well as many of the SEND subteams, such as Animal Rule, Safety Pharmacology and Dermal/Ocular.
Nate Freimark is Vice President - Clinical Programming and Data Standards at The Griesser Group. Nate was the CDISC ADaM team lead from 2010-2017, a member of the CDISC GGG (Global Governance Group), one of the ADaM trainers and a member of the SDS Oncology, QS and Compliance subteams. Nate is also a member of several PhUSE teams (working on improving data quality and site selection standards) and the ADaM lead for many CFAST Therapeutic Area User Guides (TAUGs). He has been a member of the ADaM team since 2005, a member of the ADaM Leadership Team since it’s creation, and has been “doing CDISC” since 2004. Nate has been involved in ADaM Education since it’s 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.
Kit Howard has over 30 years of experience in many facets of clinical research, including the development of data and process standards for exploratory through post-marketing clinical trials. She joined CDISC staff 6 years ago, but first volunteered with CDASH beginning in 2007. She is currently Senior Director of Education and Standards Development for CDISC, both developing and presenting online and classroom training. She is actively involved in data capture and regulatory submission data standards for drug, biologic and medical device research, with particular interest in their use by both regulated industry and academia. She serves as co-leader of CDISC’s Medical Device Standards Development team, as well as participating in CDASH, CDISC’s Global Governance Group, and most recently on CDISC’s COVID-19 development of guides for new and ongoing clinical research during the pandemic.
Kit is active in the professional community, speaking at conferences, presenting standards and quality-related talks and webinars. Prior to joining CDISC’s staff, she developing public health and clinical research informatics online courses for Michigan State University, and spent 10 years as Kestrel Consultants, where she guided research organizations in evaluating their data standards-readiness and in designing and implementing standards, specializing in "protocol through clinical study report" implementations that incorporated both process and CDISC standards.
Sam Hume leads the CDISC Data Science team, which collaborates with CDISC staff and stakeholders to develop tools and standards that support clinical and translational data science. Dr. Hume directs delivery of the CDISC Library, our standards metadata repository, co-leads the CDISC Data Exchange Standards team, and leads the CDISC Real World Data efforts. He has 25 years’ experience in clinical research informatics and has held a number of senior technology positions in the biopharmaceutical industry. Dr. Hume holds a doctorate in Information Systems.
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.
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.
Kristin Kelly is an Associate Director at Pinnacle 21 in the Clinical Data Standards group. Kristin has over 10 years of experience working in the pharmaceutical industry primarily focused on clinical data standards. Prior to joining Pinnacle, Kristin was an Associate Director at Merck in the Global Clinical Data Standards (GCDS) group. She was also worked a consultant in Data Standards Consulting (DSC) for Accenture (formerly Octagon Research Solutions). She provides guidance on CDASH and SDTM standards to both internal project teams and external clients. Kristin is also involved with the CDISC SDS team, CFAST Initiative TAUG teams, SEND Core Team, as well as several PhUSE CSS Working Groups. Kristin has led several SDTM conversion projects for submission to both CDER and CBER that have resulted in FDA approvals. Kristin holds a B.S. in Biology from Saint Joseph’s University.
Éanna Kiely is the lead CDISC Consultant at ClinBuild and he volunteers to CDISC on behalf of Syneos Health.
He has been working with CDISC standards since 2008 in a variety of roles including Data Manager, Standards Librarian, SDTM Legacy Data Mapper and Line Manager/Product Owner of CDISC Metadata Repository. He has led 2 CDASH/SDTM Standards Implementation and Governance projects and has been a CDASH/SDTM/EDC Subject Matter Expert on multiple others for both (bio)pharma and CROs across Europe.
He has been an active CDISC volunteer since 2013 when he joined the SDS Questionnaires Ratings and Scales (QRS) sub-team and published a number of QRS Supplements, submitted controlled terminology and worked on projects. He joined the CDASH team in 2015 and is an author CDASHIG 2.0 and Model 1.0. He is currently a member of both the SDS and Laboratory Controlled Terminology teams. He is an author on SDTMIG 3.3 and the Malaria TAUG V1.0. He is an authorized CDISC Instructor in Training for both CT and SDTM.
He is currently leading the SDS Lab Units Representation team and is a member of the SDS Multiple Subject Instances (MSI) team that is modeling rescreening and reenrollment subjects in SDTM.
He is a member of the European CDISC Coordinating Committee where he helps organize the European Interchange and represents CDISC within Europe. He frequently presents on CDISC topics.
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.
Sandra is a Senior Principal Clinical Data Standards Consultant at PRA Health Sciences, helping implement ADaM. She is a former ADaM Team Lead, and previously led the ADaM sub-team for the Occurrence Data Structure (OCCDS) v1.0 and co-led the finalization of ADaMIG v1.1. An active ADaM team member since 2001, she proposed structures that later became ADSL and OCCDS and reviews draft ADaM documents with a focus on the fundamental principle of traceability. Sandra has worked in the pharma/biotech industry since 1993, at both sponsor and vendor organizations, in a variety of roles, including programmer, statistician, data manager, and filing team lead.
Mike Molter is the Director of Statistical Programming and Technology at Wright Avenue in Cary. At Wright Avenue, Mike is responsible for providing statistical programming support, as well as placing and managing Wright Avenue resources inside pharmaceutical, biotech, and CRO clients. He also oversees the management and development of new technologies aimed at streamlining the flow of clinical trial metadata through an organization.
Mike has been involved in SAS programming since 1999, in clinical trials since 2003, and in industry data standards since 2005. He has been a member of the CDISC XML Technologies team since 2010. Professional interests are centered around the use of cutting edge technologies to optimize the use of clinical trial metadata throughout the lifecycle of a clinical trial. Personal interests include cycling, swimming, and reading.
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.
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.
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.
Taku Shimizu is currently a Statistical Programmer at IQVIA Services Japan K.K. He has been a SDTM specialist for 9 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.
Lauren is a Certified Clinical Data Manager with over 15 years experience in data management, programming and project management. She has managed clinical and statistical programming teams in both North America and Europe and developed CRF standards for an international CRO as well as several client organizations. Lauren is the 2012 Chair of the CDISC Advisory Board and is part of the CDASH Leadership Team.
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.
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.
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 Director of Clinical Data Standard and Data Submission in the Statistical Programming group of Cytel, Inc.
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.
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.
Peter Van Reusel is the CDISC Chief Standards Officer since June 2018, providing executive leadership to the development and implementation of CDISC Standards and Initiatives. He designs and executes the technical vision for clinical data standards while building a culture that meets the needs of regulators, CDISC members, partners, researchers and ultimately patients so that CDISC standards are broadly accepted and utilized.
He is passionate about data standards and implementation solutions that work. He is an advocate for CDISC and loves complex challenges.
He started his career as a database designer at Janssen Pharmaceutica, originally designing and installing clinical databases, later on taking responsibility as a data steward to ensure consistency of database structures between US and European counterparts. In 2003, he started working at Tibotec, where he helped implement industry standards, such as the CDISC models. Tibotec was one of the first companies to successfully perform a native CDISC submission.
In 2007, Peter started the Business & Decision Life Sciences CRO, which is highly specialized in CDISC Data Standards. Over the years, Peter and his team supported many companies in converting clinical legacy data for regulatory submissions. In addition, he has provided leadership in a variety of CDISC implementation projects.
Peter is a certified CDISC SDTM and CDASH trainer since 2008, delivering CDISC trainings and expertise all over Europe. In addition he was the chair of the European CDISC Coordinating Committee, responsible for organizing the European CDISC Interchange.
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 R&D IT, supporting CANDA (Computer Assisted New Drug Applications) submissions. He subsequently moved to Regulatory Affairs and Publishing where Gary helped to create numerous NDAs, BLAs 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 DM department. In this role, Gary supported CDISC standards for data preparation within DM and Biostatistics, both for submission using SDTM and in the data collection and cleaning processes of Data Management. Gary joined the CDASH initiative in 2006 and has been a core member of CDASH since. In 2019 Gary became an independent contractor, consulting and training on CDISC standards. He continues to actively participate on the work on many of the CDISC standards including SDTM, CDASH and CDISC SHARE. 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.
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.
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.
Richann Watson is an independent statistical programmer and CDISC consultant with over 20 years’ experience working in the pharma industry. She is a member of the ADaM team, co-leads the ADaM Oncology sub-team and serves on the ADaM Traceability sub-team. Richann is an Executive Committee member of PharmaSUG. She is also a member of Southeast SAS Users Group (SESUG) Executive Committee and is actively involved with SAS Global Forum and other SAS User Groups.
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.
Nick Wells is a Senior Principal Biostatistician with Syneos Health, joint head of the Biostatistics Consultancy Group (BCG) and a member of the Syneos Health ADaM Standards Team. Regionally based in the UK, Nick has over 15 years of experience in the pharmaceutical sector across Biostatistics and Data Management, and has been implementing ADaM standards since 2014.
As part of the internal ADaM standards Team, Nick has been responsible for designing and implementing templates and process for ADaM specification and Analysis Results Metadata, including rolling out training for the wider teams, and has been involved in a number of successful CDISC submissions to regulatory agencies as a Biostatistics Study Lead.
Mario Widel is an Independent CDISC consultant. 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 on 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.
Diane Wold is Senior Director, Standards Development and Modeling at CDISC. She came to CDISC in 2015 with 30 years of experience in the pharmaceutical industry in statistics and data standards. She has been an SDS team member since 2002, and led the development of the trial design model within the SDTM. She was a member of the Protocol Representation Group and the early SHARE project. She worked on the development of the BRIDG model and the mapping of the SDTMIG to BRIDG. She has worked on numerous Therapeutic Area User Guides, where she introduced the use of concept maps. She has been involved in the review and governance of CDISC standards since 2012.
Fred is Senior Manager and Lead of the Data Standards Consulting Group within Accelerated R&D Services, a group he has led since 2007. He 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). Fred is a founding member of the SDS Team (1999), the SEND Team (2002), and the Devices Team (2007), and has led or co-led these for many years; he currently serves on the Leadership Teams of all three. Fred is currently a member of the CDISC Standards Review Council (SRC), the CDISC SDTM Governance Committee (SGC), and the CDISC Technical Leadership Committee (TLC). He has been a member of many other CDISC SDTM-related teams since 1999, and is providing SDTM expertise to therapeutic-area projects conducted as part of the CFAST initiative.
Fred joined Accenture via the Octagon acquisition in 2012. He joined Octagon in 2006, coming from Procter & Gamble Pharmaceuticals, where he was the Global Data Standards Manager in the Clinical Data Management Department. This position was preceded by many years as a Senior Toxicologist at P&G, supporting Rx and OTC products. Fred has a Ph.D. and an M.S. in Biochemistry from the University of Massachusetts in Amherst, and a B.S. in Biology from Springfield College in Springfield, Massachusetts.
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.
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.
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 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.