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.

Sowmya Nagamanickam
Sowmya Nagamanickam

Senior Statistical Programmer
ICON


Volunteer Spotlight May 2024

We are proud to feature Sowmya Nagamanickam, Senior Statistical Programmer at ICON, in our Volunteer Spotlight. Since joining the CDISC Biomedical Concepts project in August 2023, Sowmya has played a crucial role in curating Biomedical Concepts and SDTM Dataset Specializations for the Digital Data Flow pilot study. Her contributions have extended to supporting the CDISC Oncology SDS team in creating standards for LUGANO disease response. Sowmya's expertise in statistical programming and her dedication to enhancing CDISC documentation and standards make her a valuable asset to the CDISC community! 

Steven J. Hovjacky
Steven J. Hovjacky

Senior Manager for Design Manufacturing and Controls
Altria Client Services


Volunteer Spotlight April 2024

Steven Hovjacky serves as the Senior Manager for Design Manufacturing and Controls at Altria Client Services, playing a key role in the Tobacco Implementation Guide (TIG) v1.0 project's Product Description Workstream. He has been volunteering with CDISC for nearly two years, leveraging his extensive experience from the tobacco industry's regulatory evolution since 2009. Although Steve's professional background is primarily in product development and manufacturing, his work closely aligns with the principles of clinical research. Steve’s advice for working with CDISC standards is to “listen to the concerns of your team members, learn from the expertise of CDISC professionals, and conduct thorough research to ensure your contributions are meaningful and valuable.”

Donna Sattler
Donna Sattler

Director, Head Standards Operational Management
Bristol Myers Squibb


Volunteer Spotlight February 2024

Donna Sattler, with 15 years at CDISC, champions asking questions and leveraging CDISC resources to navigate Standards, showcasing the power of volunteerism in evolving clinical research. Donna advises, “Do not be intimidated or assume you are expected to know everything. All the tools that are out there to help you navigate Standards are overwhelming. As a CDISC mentor, it’s our job to help one another”.

Coretta Thomas, MPH
Coretta Thomas, MPH

Clinical Research Scientist and Data Manager
The University of Alabama at Birmingham


Volunteer Spotlight November 2023

Coretta Thomas, serving as Scientist I in Biostatistics and Data Manager at the Neurofibromatosis Consortium, has dedicated nearly a year to volunteering with CDISC. She's driven by the challenge of bringing CDISC standards into academic settings, aiding institutions in their transition. Starting her clinical research career in HIV/AIDS clinics, Coretta now plays a key role in developing the SDTM education for the Rare Diseases Therapeutic Area User Guide. Her key tip for mastering CDISC Standards: "Engage in volunteering for expert insights and collaborate with CDISC partners for successful standard implementation."

Karl Wallendszus
Karl Wallendszus

Senior Analyst/Programmer
Oxford Population Health


Volunteer Spotlight October 2023

We're delighted to feature Karl, who joined the Analysis Results Standard team in late 2020. Inspired by a webinar, Karl saw the potential for end-to-end standardization in CDISC and jumped at the rare chance to help develop a new standard. With a background in zoology and biological computation, he brings a unique perspective to clinical research. Currently at Oxford Population Health, Karl is excited about the ARS v1.0 release, particularly its capabilities for automating analyses and reusing results. His tip for mastering CDISC Standards: "Volunteering offers a deeper understanding and diverse perspectives."

Erin Tibbs-Slone
Erin Tibbs-Slone

SEND Senior Specialist
Charles River Laboratories


September 2023 Volunteer Spotlight

We are excited to spotlight Erin Tibbs-Slone and to recognize more than six years of volunteering with CDISC!

Erin's journey with CDISC began in 2017, fueled by her desire to break out of siloed work environments and collaborate on a broader scale. With a focus on SEND and a passion for process improvement, she's been instrumental in the recent release of the SEND Tumors Combinations v1.0 guide, a resource that promises to unify terminology and understanding across the field. Erin's tip for working with CDISC Standards: "Always refer back to your standards documents, as interpretations and understanding are constantly evolving".

Kevin Burges
Kevin Burges

Head of Product Management
Formedix


August 2023 Volunteer Spotlight

We are excited to spotlight Kevin Burges and to recognize more than 20 years of volunteering with CDISC!

Kevin has long been a leader in the development of ODM, and he contributed significantly to the recently released ODM v2.0 standard. His extensive knowledge of ODM stems from his long tenure as a key member of the CDISC Data Exchange Standards team, as well as his experience developing solutions using ODM. Kevin has a keen eye for detail, deep technical knowledge, and a collaborative style that make him invaluable to the team.

David Neubauer
David Neubauer

Standards Engineer
IQVIA


July 2023 Volunteer Spotlight

With a strong knowledge of SDTM, David began volunteering for CDISC over 6 years ago after implementing the standards for many years. David's leadership and domain knowledge are essential in driving the standards forward, making him an invaluable asset to many workstreams, such as SDS and CORE.

He is the co-lead of the SDS SUPPtoNSV team and actively contributes to various CDISC teams, including SDS, the SDS Oncology subteam, and CORE.

Akira Soma
Akira Soma

Solution Director
Oracle Japan


June 2023 Volunteer Spotlight

Akira serves as Chair of the CDISC Japan Coordinating Committee (J3C), managing a variety of initiatives and overseeing such activities as the upcoming 2023 CDISC Japan Interchange. An SDTM expert, he has been involved with the CDISC Japan User Group SDTM team for over 10 years and is an authorized instructor in SDTM Theory and Application. Under Akira’s leadership, the J3C is coordinating a workshop in November to encourage the use of CDISC Standards in academia.