CDISC SDTM SME
Employee of Clinical Solutions Group an IQVIA business, on behalf of Gilead Sciences
June 2021 Volunteer Spotlight
Smitha Karra co-leads the CT Relationships team, which recently released the Controlled Terminology Relationships v1.0 for SDTM v1.4 and SDTMIG v3.2 . She also serves on the sub-team that develops SDTM QRS Supplements.
Data Standards Consulting Group
May 2021 Volunteer Spotlight
Richard served as team lead of the recently released version 2.0 of the Study Data Tabulation Model Metadata Submission Guidelines. He is now volunteering on the team to develop ADaM Metadata Submission Guidelines.
Principal Global Clinical Dictionary Manager
This spotlight was featured in December 2020.
Anna serves on several Controlled Terminology teams and represents Controlled Terminology on the Global Governance Group.
Associate Director, Clinical Data Standards Architect – Data Analysis & Reporting
Johnson & Johnson
This spotlight was featured in September 2020.
Tatiana leads the ADaM Team.
Executive Vice President
Beijing Data Science Express Consulting Co., Ltd.
This spotlight was featured in June 2020.
As chair of the C3C, Victor has led various activities to promote CDISC in China. He coordinates the translation of CDISC standards into Chinese. Victor is also an authorized instructor in ADaM and SDTM.
Senior Research Scientist
Bristol Meyers Squibb
This spotlight was featured in March 2020.
Bill has been contributed his expertise to the SEND team for over 10 years and served as Team Leader for three years. He currently advises SEND Team Leadership.
Senior Principal Statistical Programmer
This spotlight was featured in December 2019.
Dmitry serves as a volunteer on the Data Exchange Standards team and is a contributor to the team's projects - ODM v2.0 and Define-XML v2.1. He is an open source developer actively using CDISC Library to build tools that make it easier to implement the CDISC standards.
Consultant Data Standards - Clinical Information and Process Automation
Eli Lilly and Company
This spotlight was featured in September 2019.
Mike led the CDASH Team from 2015 - 2020, bringing enthusiasm, expertise and dedication at every twist and turn.
Manager, Data Intelligence, Biostatistics & Data Management
Daiichi Sankyo Co., Ltd.
This spotlight was featured in June 2019.
Yumiko led the CDISC Japan User Group (CJUG) ADaM team from 2011 - 2018, who produced the Japanese ADaM summary document for learners (Hajimete-no-ADaM).
Biomedical/Clinical Research Information Specialist
Enterprise Vocabular Services (EVS), National Cancer Institute Contractor
This spotlight was featured in September 2018.
Jordan leads the Controlled Terminology team.
Associate Director, Data Standard Expert
This spotlight was featured in March 2018.
Group Lead, Program Data Management Group, Japan
This spotlight was featured in June 2018.
Hidetoshi chaired the Japan CDISC Coordinating Committee (J3C). His commitment to advancing the awareness of CDISC in Japan has been significant in promoting the use of CDISC standards in the region.
Consulting Solution Senior Director
Oracle Health Sciences
This spotlight was featured in December 2017.
Joerg served as chair of the E3C for many years and remains an active member.
Kamiar “Mike” Hamidi
Associate Director, Global Clinical Data Standards
Merck & Co.
This spotlight was featured in June 2017.
Mike has served on various CDISC teams since 2010. His blend of enthusiasm, commitment and strong subject matter expertise have led him to positions of leadership and responsibility.
Director of Global Integrated Standards
This spotlight was featured in September 2016.
Trisha co-chaired the CDASH team, co-led the Rheumatoid Arthritis Therapeutic Area team, served as representative on the CDISC Advisory Council, member of the CDISC Technical Leadership Committee, member of the EHR-to-CDASH (E2C) team, and the UCB representative on the TransCelerate Data Standards and eSource work streams.