Teams at Madrigal Pharmaceuticals

Lead and execute statistical programming across clinical development: develop, validate, review, and maintain SAS programs; review SDTM/ADaM/TLFs and Define.xml; support NDA/BLA submissions and submission validation; establish programming standards, QC procedures, and automation; and coordinate work with biostatisticians, CROs, and cross-functional teams.

Lead end-to-end data management for clinical studies including DMPs, EDC setup and UAT, query management, external data integrations, data cleaning, metrics monitoring, database lock, vendor oversight, and cross-functional collaboration to ensure regulatory-compliant, high-quality trial data.

Lead GMP API Quality Assurance for external CMOs/CDMOs, owning API quality strategy, oversight of batch review, deviation/CAPA, change control, inspection readiness, partner governance, tech transfer support, and mentoring QA staff to ensure ICH Q7 and global GMP compliance.