International Day Of Women in Statistics and Data Science

Sonali Garg is an accomplished statistical programming leader with nearly 20 years of experience across the pharma, biotech, and CRO industries. She holds a graduate degree in biostatistics and an undergraduate degree in statistics.

Throughout her career, Sonali has guided numerous compounds through complex global submission, approval, and post-approval processes. She has prepared multiple successful submissions to the FDA and EMA, navigated regulatory audits, and worked directly with regulators and senior management. A CDISC Subject Matter Expert, she provides critical oversight for core regulatory documents.
Her extensive therapeutic expertise spans Ophthalmology, Oncology Solid Tumors, and Hematological Cancers. A strategic leader skilled in CRO oversight and vendor management, Sonali excels at aligning cross-functional teams while translating complex outputs for diverse audiences.