Principal / Associate Director, Statistical Programming

Role: Lead and support statistical programming activities for Madrigal's clinical development across multiple phases, ensuring high-quality deliverables aligned with regulatory standards. Responsibilities: develop and validate SAS programs for data transformation, analysis, and reporting; review CRO deliverables including SDTM, ADaM, and submission packages; collaborate with cross-functional teams like biostatistics, data management, and regulatory operations; support regulatory submissions such as NDAs/BLA, pooled analyses, and safety/efficacy summaries; contribute to programming standards, automation, and process improvements, including AI tool evaluation. Requirements: Bachelor's degree in a relevant field; 10+ years' industry experience with regulatory submission involvement; strong SAS programming skills, including macro development; knowledge of R preferred; thorough understanding of ICH, GCP, and CDISC standards (SDTM, ADaM); prior CRO oversight experience; effective cross-functional collaboration skills. HighValue: expertise in clinical data standards, regulatory submission support, and automation in a biologics or small molecule clinical trial environment, with Phase 3 research focus. WorkSetup: not specified; potential for cross-functional collaboration and automation initiatives.