Volunteer Spotlight

CDISC’s strength derives from the diverse perspectives of our community. Whether coming from a pharmaceutical organization, academic institution, regulatory agency, non-profit, or beyond, our volunteers bring a range of experiences and backgrounds that drive more meaningful clinical research. We invite you to read about our volunteers who contribute their expertise to facilitate the development of standards that are open and available to all.

Carey Smoak

Retired Statistical Programmer

August 2021 Volunteer Spotlight

Carey co-founded and co-led the CDISC Medical Device team since its inception in 2006. The team is currently working on the publication of the first version of the ADaM Implementation Guide for Medical Devices along with its Conformance Rules, which are anticipated to be released by the end of this year.

Bhavin Busa

VP and Head of Clinical Data Services and Operations
Vita Data Sciences

July 2021 Volunteer Spotlight

Bhavin Busa volunteers on the team that is developing the new Analysis Results Standard. He also serves as a Board Member for the CDISC Open-Source Alliance (COSA). Bhavin recently participated on the CDISC 360 project and co-authored the 360 White Paper.

Smitha Karra

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.

Richard Lewis

SDTM Consultant
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.

Anna Pron-Zwick

Principal Global Clinical Dictionary Manager
AstraZeneca

This spotlight was featured in December 2020.

Anna serves on several Controlled Terminology teams and represents Controlled Terminology on the Global Governance Group.

Tatiana Sotingco

Associate Director, Clinical Data Standards Architect – Data Analysis & Reporting
Johnson & Johnson

This spotlight was featured in September 2020.

Tatiana leads the ADaM Team.

Victor Wu

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.

Bill Houser

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.

Dmitry Kosolov

Senior Principal Statistical Programmer
Parexel

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.