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.
Jozef Aerts is professor in Medical Informatics at the University of Applied Science FH Joanneum in Graz, Austria. He is also an active CDISC volunteer since 2002, and one of the main developers of the ODM and SDM-XML standards, with also contributions 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 (CDISC Registered Solutions Provider) 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).
Kiyomi Ando is a clinical data manager (CDM) with 15+ years of experience working in a global pharmaceutical company, a Japanese pharmaceutical company, and a Japanese clinical research organization (CRO). She has been in charge of data management in 50+ clinical studies and has designed 20+ CRFs. She has participated in the CRF standardization project in a global pharmaceutical company. Kiyomi has implemented CDISC Standards in a CRO and a pharmaceutical company in Japan since 2005. She has also experience as a clinical research associate in a global pharmaceutical company and as a pharmacist in hospital. She has knowledge of the process from data acquisition in hospital to study data tabulation for submission.
Yoshihiro Aoyagi is the section head in Information Technology Management Section at National Cancer Hospital East in Japan. His main areas of expertise are system integration of infrastructure, data management and consultation for clinical trial systematization. He developed various information systems such as open source EDC system or Remote SDV system to improve utilization of information resource in the hospital. Yoshihiro has also researched the usage of hospital information system data and estimate its reliability and transparency. Previously, he had worked for clinical pharmacist drug information specialist.
Lauren Becnel focuses on informatics technologies at CDISC, including our metadata repository, SHARE, which houses all CDISC standards. Dr. Becnel works at the intersections of clinical research, translational research and healthcare, ensuring the standards remain relevant for regulated research, academic research centers and precision medicine. She has over 10 years’ experience in biomedical informatics and research IT, with seven years’ experience leading large, diverse technical teams and a high-performance research computing center at Baylor School of Medicine where she served as Assistant Professor in the Departments of Medicine, Hematology/Oncology Section, and Molecular and Cellular Biology. For the past four years, she has served on the Steering Committee of the collaborative BRIDG Translational Research Domain Analysis Model (CDISC, HL7 and ISO, NCI and FDA), which harmonizes the CDISC Foundational Standards.
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 for Medical Affairs, managing a team of global data managers working on 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 has also contributed to the creation of the Vaccines Reactogenicity TAUG.
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.
Dorina Bratfalean has more than 20 years of experience as a researcher in biotechnology in academia and private biotech companies working on different European Project Frameworks (FP5, FP6, FP7). Dorina holds a PhD in Computer-aided Bioprocess Engineering in Chemical Engineering from Babes Bolyai University, Faculty of Chemistry and Chemical Engineering, in Cluj-Napoca, Romania.
In 2010, she became senior data manager in the fields of biomarker development and translational medicine. She has developed eCRFs by implementing the CDASH model and has developed ETL SDTM data integration models throughout more than 60 clinical studies in various patient populations to validate markers of liver, kidney, and cardiovascular toxicities.
In 2014, Dorina joined the CDISC European Foundation team to work on IMI projects as a data standards adviser. Dorina is an active member in the CDISC Protocol Terminology team, CDISC SDTMIG for Pharmacogenomics/Genetics team (PGx), and the Therapeutic Area Data Standards User Guide for Vaccines team. She is also a member in the tranSMART community standards working group to develop the representation of clinical data trees as a CDISC SDTM model in tranSMART i2b2.
Nancy Brucken is a Standards Engineer in the Data Standards and Innovations group at Syneos Health, 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 is the owner of Next Step Clinical Systems LLC a consulting company focused on facilitating the process of implementing CDISC standards. Sally was a founding member of the CDISC XML Technologies team and still volunteers as a team co-lead. She participates as a DefineXML team representative in the ADaM Metadata Team in the CAB Validation Project and on the Customer Advisory Board Validation Project. She is an ODM certified instructor. Prior to founding Next Step, Sally spent 8 years at Lincoln Technologies, Phase Forward and Oracle where she was the business and development lead for WebSDM and Empirica Study. Sally has over 25 years experience developing and implementing commercial clinical research software applications.
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.
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.
Rhonda Facile brings over 25 years of clinical development experience and has worked in a global CRO, as well as pharmaceutical and biotechnology companies in the United States and abroad. She has worked with CDISC for over eight years developing and contributing to the CDASH (CRF) standards program and the CDISC SHARE project. Ms. Facile currently manages the CFAST therapeutic area standards program as well as facilitating and ensuring that all CDISC standards projects progress and comply with CDISC development processes and policies. She holds a BA degree from the University of Texas at Austin and an MS in Organization Leadership and Ethics from St. Edwards University.
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).
Nate is Vice President - Clinical Programming and Data Standards at The Griesser Group. Nate is the current CDISC ADaM team lead, a member of the CDISC TLC (Technical Leadership Committee), one of the ADaM trainers and a member of the SDS Oncology and Compliance subteams. Nate is also a co-lead of several PhUSE teams and is 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 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.
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 is the currently Director of Education 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, and serves as co-leader of CDISC’s Medical Device Standards Development team. She also serves on the CDASH Leadership team, the CDASH Governance Committee, and the SDTM Governance committee.
Kit is active in the professional community, speaking frequently at conferences, presenting standards and quality-related talks and webinars, and developing public health and clinical research informatics online courses for Michigan State University. Previous to joining CDISC, Kit worked 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 is Head of Data Exchange Technologies at CDISC. At CDISC he works on the SHARE project and co-leads the XML Technologies team. Sam has over 20 years of work experience in clinical research informatics. Previously, he worked as Director of IS Architecture at AstraZeneca, VP of Technical Operations at Phoenix Data Systems and Chief Technology Officer at CB Technologies. Sam has a doctorate in information systems specializing in healthcare 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 HMS Analytical Software GmbH 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. She is the current lead of the ADaM metadata sub-team. Since work on metadata is very much related to Define-XML, Monika also became a member of the CDISC Define-XML team and has just been appointed as CDISC authorized Define-XML instructor. She is also 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.
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.
Shannon Labout is a Certified Clinical Data Manager (CCDM®) with more than two decades of experience implementing and managing healthcare and research technologies and data, providing team and organizational leadership, and developing and delivering best practices in clinical data management and standards implementation for industry, regulators and academia in multiple therapeutic areas of drug and medical device research.
Since 2007, Shannon has been an Authorized CDISC Instructor, and has been deeply involved in developing online and classroom courses for CDASH, SDTM, and other CDISC topics for industry, regulators and academic researchers.
Shannon is currently the owner and principal of Data Science Solutions LLC, a consultancy helping organizations implement best practices and data standards into their workflow and culture. She has served on the Board of Trustees for the Society of Clinical Data Management (SCDM) since 2014 and is the 2018 SCDM Board Chair.
Sarah McLaughlin has 25+ years experience in health research as a SAS progammer and data standards expert. She is knowledgeable about CDASH, SDTM, controlled terminology and ADaM. She has volunteered on the CDASH and Diabetes TAUG teams. Sarah has an MPH in Epidemiology.
Sarah is highly proficient in clinical research, from development of CRFs, through clinical database design, SDTM mapping, creation of analysis files, production of tables, listings, figures to submission to regulatory authorities. She has experience in phase I-III clinical trials, healthcare utilization and epidemiological studies. Sarah’s therapeutic experience includes neurology, infectious diseases, substance abuse disorders, maternal/fetal health, and immunology.
Sandra is a Senior Principal Clinical Data Standards Consultant at PRA Health Sciences, helping implement ADaM. She is the ADaM Team Lead, part of the ADaM Leadership Team (ALT) and reviews draft ADaM documents with a focus on the fundamental principle of traceability. Previously, Sandra 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. 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.
Dr. Erin Muhlbradt is a contractor for the National Cancer Institute’s Enterprise Vocabulary Services (NCI EVS) and is the NCI EVS project lead for the Clinical Data Interchange Standards Consortium (CDISC) terminologies. Erin has over 5 years’ experience in the bioinformatics and pharmaceutical industries, including data standardization, database and metadata repository development, and terminology development.
She manages a team at EVS that is responsible for the development and maintenance of CDISC controlled vocabularies in use by the pharmaceutical industry and the US Food and Drug Administration (FDA). Her duties include project management, biomedical and clinical trial subject matter expertise, terminology development, quarterly terminology publications, managing the CDISC terminology change request mechanism, and developing the content around the CDISC metadata repository. Previously, Erin was a doctoral candidate at Georgetown University in the Tumor Biology department and she performed her thesis work in laboratories at Georgetown University and Columbia University.
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 is active on all CDISC controlled terminology teams, a member of the management team for the CDISC SHARE project and active on therapeutic area standards development teams.
Barrie has over 18 years’ experience in biostatistical programming and clinical data management, managing and implementing data standards functions, and leading a governance body to oversee the use of standards. Working for such CDISC member organizations as GSK, Amgen and Onyx, Mr. Nelson led and contributed to many process improvement initiatives where standards were at the heart of these projects, with specific goals of cycle-time reduction, reduced operational costs and increased quality. He has been a volunteer and leader for CDISC teams since 2003, and spearheaded the development of the Oncology domains for SDTM.
With over 25 years in this industry, Jon is a highly experienced consultant in pharmaceutical drug development life-cycle projects. He has been a member of the ADaM team since 2006, and since that time, most of his consultant work has focused on CDISC ADaM implementations in support of statistical programming, study integration and regulatory filing activities. Of note, he was the first authorized CDISC ADaM trainer within Europe and was responsible for the analysis data and reporting of the industry's first ADaM compliant regulatory submission to the FDA. In later years, he has been instrumental in numerous regulatory data filings with the FDA and European authorities on projects involving Lundbeck, Takeda, Forest Labs, Novo Nordisk, Merck, Abbott, Solvay, Wyeth, Novartis, and Sandoz.
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 an analyst at Quintiles Transnational Japan K.K. He has been a SDTM specialist for 5 years with practical experience of SDTM development (40+ protocols) and implementation with multiple pharmaceutical companies.
He has managed all aspects of the SDTM, recently with define.xml, development and operation processes (schedules, designs, productions, tests, releases, editorials and maintenances) with efficiency. His skills are SAS, Pinnacle 21, and coordinating Data Manager and Biostatistician peacefully in a view of SDTM Specialist.
Taku joined LAB team in 2006. Since 2009, he has been an active member on the SDTM team. He earned a B.S. in Biochemistry from the Kyoto Institute of Technology.
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.
Dana Soloff is the owner of Mandira Consulting LLC, a company specializing in helping Pharmaceutical companies define and integrate CDISC standards into how they do business across the development lifecycle, efficiently and pragmatically. Dana is a long-time member of the CDISC ADaM team and is currently supporting the ADaM Integration and Education sub-teams. Before forming Mandira Consulting, Dana spent 20 years in the Health Care and Pharmaceutical Industries in Statistical Programming, Healthcare Data Systems Outsourcing, Clinical Data Standards Governance, and MDR implementation.
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 of experience in the field of Clinical Research in the area of Data-Management and Statistical Programming with different roles in Academic Organizations, CROs and Pharmaceutical Industries, in Italy, Switzerland and the UK.
The application of CDISC standards in different therapeutic areas is part of his core expertise since 2003 in particular in the context of data submission to health authorities such as the FDA and PMDA.
Angelo is a member of the CDISC ADaM Team as well as the CDISC European Committee where he is responsible of the Italian-speaking CDISC 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.
Peter Van Reusel 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 is involved 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 is the chair of the European CDISC Coordinating Committee, responsible for organizing the European CDISC Interchange.
In 2016, Peter has ended his role in the as a CRO Director and has refocused his career to providing his data standards implementation expertise to various companies.
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 SHARE. Gary currently work for Quintiles in Innovation, a group focused on new and innovative products, where he is a part of a team focused on EHR data use for clinical research.
Aimee Wang is senior project manager in clinical trial data management at MSD R&D (China) Co. Ltd. Aimee has been working in pharma industry for more than 9 years. She is very experienced on project management of clinical trial data management and very strong E2E data management knowledge for various therapeutic areas, including CRF design, database programming/testing, data cleaning, DBL and reporting, etc.
John Wang is Associate Director, Statistical Analysis, at dMed Biopharmaceutical Co., Ltd. He has 10+ years extensive statistical analysis experience in all phases of clinical trials, is familiar with different kinds of programming languages and system tools in clinical research. Before he joined dMed, he was Manager of SAS Programming at Johnson & Johnson China since 2009. Prior to that, he was associate manager of SAS programming for four years at Global Research Services, LLC. He is Vice Chair and team lead for the SDTM group in C3C (China CDISC Coordinating Committee). He has very extensive experience using CDISC fundamental data standards such as CDASH, SDTM, ADaM, Controlled Terminology and define.xml. He became a CDISC authorized SDTM Instructor in early 2016.
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 and is currently the co-lead of the ADaM Oncology sub-team. In addition, Richann is a member of the ADaM IG1.2 and the ADaM Traceability sub-teams. She is an Executive Committee member for PharmaSUG and is the chairperson for the local SAS user group in the Cincinnati/Northern Kentucky area 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.
Mario Widel is a Principal Statistical Programmer at Covance. 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.
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.
Hiromi Yamamoto is a reviewer of Advanced Review with Electronic Data Promotion Group at Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. She is a Certified Clinical Data Manager (CCDM) from the Society for Clinical Data Management (SCDM), and she has 12 years of data management experience at Eli Lilly. She is highly competent in all aspects of data management, across all phases of clinical trial research and in many therapeutic areas. Prior to this, she worked in clinical research operations at Eli Lilly, is a licensed pharmacist in Japan, and holds a Master degree in Pharmacy from Kyushu University and MBA. She will provide CDISC licensed training within PMDA only.
Seiko Yamazaki is a statistical analyst and a programmer at CMIC. Seiko obtained her master’s degrees in applied statistics and clinical psychology. She has been working on projects that require compliance with the CDISC standards. She is also active in implementing the ADaM standard in her role at CMIC. Her current job responsibilities include creating statistical analysis plans/mock-up plans, specs for analysis datasets, and creating tables, figures and listings.
Lily Zhao is Senior Director of Global Data Operations at PAREXEL. Lily holds a medical degree, and has been in the clinical research industry for 14 years after her 3-year career as a physician. She has rich project experience for both data management and project leadership in various therapeutic areas and has been using CDASH for CRF design and Dataset setup since 2008. She is actively involved in the CDISC standard-relevant activities in China, which include user group meetings, trainings, and CDASH standard translations. Lily formally became a member of C3C (China CDISC Coordinating Committee) in 2014.