Director, Statistics
Otsuka America Pharmaceutical Inc. - Denver, CO
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Otsuka is seeking an experienced Director of Statistics to join our Data Science and AI group to provide statistical leadership and solutions to efficient phase 3b/4/Real-World-Evidence (RWE) study design, global Health Technology Assessment (HTA) and regulatory requirements on advanced statistics needs for our portfolio across therapeutic areas and indications. This role will lead statistical innovation and data insights in HTA and Integrated Evidence Plan (IEP), including efficient statistical design and execution of late-phase clinical trials and real-world studies, AI/ML-based population enrichment, Bayesian methods, RWD/external control, and collaborate closely with cross-functional teams including Global Value Evidence, Global Medical Affairs, Market Access, Regulatory, Biostatistics, Global Clinical Development and Clinical Management. Key Responsibilities: + Strategic Leadership in Advanced Statistics : + Provide expert statistical guidance for late-phase clinical trials and real-world evidence (RWE) studies across programs including Nephrology, CNS and Rare Disease. + Lead statistical contributions to HTAs and Market Access submissions, ensuring that all statistical methodologies meet the necessary regulatory and reimbursement requirements. + Contribute to the development and implementation of HTA-related statistical methodologies, such as matching-adjusted indirect comparison (MAIC), Bayesian network meta-analysis and clinical/regional input for health economic models. + Ensure that analyses supporting
Created: 2026-04-01