Radhika Kale, MS, Alnylam Pharmaceuticals

Radhika Kale is Associate Director of Statistical Programming Standards at Alnylam Pharmaceuticals, where she leads global initiatives to advance clinical data standardization across programs and vendor ecosystems. With over 18 years of experience in the pharmaceutical industry, she brings deep expertise in SAS programming, CDISC standards implementation, and regulatory submissions.

Throughout her career, Radhika has played a key role in developing and governing data standards to support efficient, high-quality clinical trial execution. She has led standards initiatives at major organizations including Bristol Myers Squibb and Celgene, contributing to multiple IND and NDA submissions across a range of therapeutic areas.

Radhika is an active contributor to the clinical data standards community and a frequent presenter at industry conferences, where she shares insights on metadata, automation, and scalable standards strategies. Her work reflects a strong commitment to improving data quality, enabling reuse, and driving innovation across the clinical data lifecycle.