• Part of clinical development team, as the statistical lead for one or more clinical programs spanning early through late phases (I-III) • Provide strategic input into clinical development plans, study strategy, study design, endpoint evaluation and selection, estimate development, and analysis strategies. • Provide innovation in clinical studies with regulatory knowledge to support efficient, risk taking during development • In collaboration with the study team, oversee and critically review protocols, SAPs, randomization schemes, and interim analysis plans. • Ensure alignment of statistical approaches with regulatory guidance and standard of care medical practices • Provide oversight of vendor statistical activities, including deliverable review, issue resolution and budgetary allocation • Lead statistical contributions to regulatory submissions (INDs, NDAs, BLAs, MAAs). • Represent Biostatistics in interactions with FDA, EMA, and other global health authorities. • Ensure statistical outputs are clear, defensible, and aligned with regulatory expectations. • Establish clear expectations for scientific quality, timelines, and accountability of Data Management and Statistical Programming. • Support hiring and resourcing strategies that scale with program needs. • Build fit-for-purpose statistical standards, templates, and processes. • In collaboration with the Clinical Development and Medical Affairs lead, ensure timely execution of clinical development plans. • Ensure compliance with ICH, GCP, and internal SOPs. • Drive consistency and quality across statistical deliverables while enabling flexibility where appropriate. • Stay current with evolving regulatory guidance and statistical methodologies. • Champion appropriate innovation, including adaptive designs, Bayesian approaches, and data-driven decision frameworks.