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.

Melanie Paules
Melanie Paules

Director, Statistical Programming
Takeda


Melanie faithfully leads the SDS Oncology Sub-team, which defines new standards and supports existing SDTM standards for oncology studies. She brings a deep subject matter knowledge of the oncology space to her role, with a foresight to understand future needs of the user community.

 

Els Janssens
Els Janssens

Executive Manager Secure Data Office
SGS Health Science


New to volunteering at CDISC, Els readily stepped in and took on the challenge of developing and QCing many machine-executable rules for CORE, which was launched at the CDISC Virtual Europe Interchange. Passionate about using standards from the start, she presented “Embracing the SDTM Mindset at Study Start to Mitigate Compliance Issues” at the Interchange.

Marc Ellison
Marc Ellison

Instem
Director, SEND Solutions


March 2022 Volunteer Spotlight

Marc brings deep subject matter expertise, along with a unique ability to communicate complex modeling issues, to his volunteerism at CDISC. His intrepid spirit has forged new paths in the continual development of SEND, CDISC’s standard for non-clinical studies. Among many accomplishments, Marc led the SEND sub-team who published the first minor release of the SENDIG, version 3.1.1, which is listed in the FDA Data Standards Catalog.

Kim Minkalis
Kim Minkalis

Programmer
The Griesser Group


February 2022 Volunteer Spotlight

Since 2009, Kim has dedicated her experience and passion for standards by volunteering on the ADaM and SDS Teams. One of the areas where she has parlayed her expertise is working with the QRS teams who develop ADaMIG and SDTMIG supplements that provide information on how to structure the data in a standard format for public domain and copyright-approved instruments.

Elisa Young
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
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
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
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
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
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
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
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
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
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
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
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
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
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.

Mike Ward
Mike Ward

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.

Yumiko Asami
Yumiko Asami

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).

Angelo Tinazzi
Angelo Tinazzi

Director, Standards, Systems, CDISC Consulting, Statistical Programming
Cytel, Inc.


This spotlight was featured in March 2019.

Angelo serves on the ADaM Team and is an authorized ADaM Instructor. He is an active member of the E3C and co-leads the CDISC Italian User Network.

Ruiling Peng
Ruiling Peng

CEO
Beijing Improve-Quality Technology Co., Ltd.


This spotlight was featured in December 2018.

Ruiling has served on the CDISC China Coordinating Committee (C3C) since 2012. She was the first person in China to become an authorized instructor of ODM and Define-XML.

Jordan Li
Jordan Li

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.

Christine Connolly
Christine Connolly

Associate Director, Data Standard Expert
EMD Serrono


This spotlight was featured in March 2018.

Christine leads the SDS team, which develops SDTM, as well as the Genomics and Biospecimens sub-teams. She also provides subject matter expertise to the CDASH and Controlled Terminology teams.

Hidetoshi Misawa
Hidetoshi Misawa

Group Lead, Program Data Management Group, Japan
Pfizer


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.

 

 

Joerg Dillert
Joerg Dillert

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
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.

Éanna Kiely
Éanna Kiely

Head, Clinical Data Stanards
UCB


This spotlight was featured in December 2016.

Éanna has served on the Submission Data Standards team, which develops SDTM, as well as on the CDASH team. Additionally, he  is an active member of the E3C.

Trisha Simpson
Trisha Simpson

Director of Global Integrated Standards
UCB


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.