Laetitia Miahle
Principal Clinical Data Standards Consultant
ICON
Volunteer Spotlight September 2024
We are excited to feature Laetitia Mialhe in our Volunteer Spotlight, celebrating her commitment as a CDISC volunteer since December 2022!
Laetitia has made a significant impact across multiple teams, including SDS QRS, QRS CT, and more recently, the CDASH team. She initially helped develop QRS supplements and later became a QRS Co-lead. In addition to her QRS work, Laetitia has also contributed to the SDTMIG 4.0 structure review as part of the SDTM team. Laetitia highlights the complexity of QRS work, which focuses on creating high-quality standards and best practices for mapping and controlled terminology. She believes collaboration is key and encourages other volunteers to actively participate and share their expertise to enhance the CDISC community’s knowledge.
Deborah Shepard, Ph.D
Pfizer - Director, Program Lead - Biomarkers, Clinical Data Acquisition
Volunteer Spotlight July 2024
Deborah began volunteering with CDISC in May 2022. Deborah emphasizes the importance of her team’s work on the Genomics Findings (GF) SDTM domain, introduced in late 2021, to structure advancing genomic data technology. The team is developing examples of various genomic data types to create a user-friendly library for the data community.
Deborah advises new CDISC volunteers to "be open to learn from other team members and to share your knowledge and experience. You’ll be amazed at the synergy that takes place when we bring our ideas together. I learn something new in every meeting and appreciate the opportunity to advance data standards for the larger community".
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
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
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
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
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
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
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.