Elisa Young
Head of Biostatistics
Accelagen
January 2022 Volunteer Spotlight
Based in Australia, Elisa recently and enthusiastically jumped into volunteering at CDISC. She serves on the CORE team, which is working to deliver a governed set of unambiguous and executable Conformance Rules for each Foundational Standard, and to provide a minimum viable product of an open-source execution engine for the executable Rules.
Kristin Kelly
Principal Consultant, Consultative Services
Pinnacle 21
December 2021 Volunteer Spotlight
Beginning in 2022, Kristin will lead the Submissions Data Standards (SDS) team who work on the SDTMIG. She is a seasoned volunteer who actively contributes her expertise to a variety of teams, including the Global Governance Group, CORE, QRS, SEND, and Controlled Terminology Relationships. Kristin is also a CDISC-authorized instructor, educating learners on SDTM Theory and Application.
Nikki Flores
Associate Director, CDM CORE (Standards, Technology & Solutions)
Gilead Sciences, Inc.
November 2021 Volunteer Spotlight
Nikki began volunteering at CDISC by contributing expertise to the development of Therapeutic Area User Guides. Her initiative, can do spirit and dedication have led to her serving as Lead of the CDASH Implementation Guide team who recently released CDASHIG v2.2 and is already working on the next release of the IG.
Nate Freimark
Vice President, Clinical Programming and Data Standards
The Griesser Group
October 2021 Volunteer Spotlight
Nate Freimark is a long-time CDISC volunteer who serves on the ADaM team, which he led from 2010 - 2017. He also contributes his expertise as ADaM lead on the development of many Therapeutic Area User Guides. Nate is a member of the SDS and Controlled Terminology teams as well as an authorized CDISC Instructor.
Ward Puttemans
Clinical Data Standards Manager
UCB
September 2021 Volunteer Spotlight
Ward co-leads the team that is developing a Controlled Terminology User Guide, which will direct users on implementing the set of codelists and valid values used with data items within CDISC-defined datasets. He also serves on the SDS Lab team.
Ward and SDS Lab team co-lead Dr. Erin Muhlbradt will be presenting at the CDISC Virtual Interchange on SDTM and SDTMIG Up-versioning and Its Effects on Specimen-based Lab Data: aka “Dude, Where’s my Data?"
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.