ACDM26 Speakers

Rajesh Saha

Senior CDISC Consultant at Certara

Rajesh Saha is a Senior CDISC Consultant at Certara and CDISC Authorized Instructor with more than 17 years of experience advancing clinical data standards, standards strategy, and technology-enabled data solutions within the global pharmaceutical industry. Originally from India and now based in Belgium, Rajesh brings a strong international perspective shaped by working across geographies, organizations, and complex regulatory landscapes.

Rajesh possesses deep expertise across the CDISC ecosystem, including SDTM, CDASH, Define.xml, Controlled Terminology and regulatory submission requirements for FDA and global health authorities. Throughout his career, he has held leadership and architect roles at CDISC, Certara, Merck KGaA, and J&J, where he led enterprise-wide standards governance, SDTM Implementation Guide upgrades, and large-scale metadata-driven automation initiatives. His work consistently focuses on bridging clinical data standards with modern technology, enabling scalable, efficient, and high-quality data flows across the clinical data lifecycle.

As a trusted standards consultant and recognized industry thought leader, Rajesh educates and partners with cross-functional stakeholders, product teams, and external customers, helping organizations align standards strategy with evolving regulatory expectations and digital transformation goals. He regularly contributes to the industry through public speaking, advisory roles, and the development of educational content, and is known for translating complex standards concepts into practical, technology-driven solutions. Rajesh frequently presents at global forums such as CDISC Interchange and PHUSE.

Outside of his professional work, Rajesh lives in Belgium with his wife and three children. He enjoys cooking and values spending quality time with his family, which keeps him grounded and reinforces his collaborative, people-focused approach to leadership.