Director, Statistics

at Otsuka America Pharmaceutical Inc. in Augusta, Maine, United States Job Description 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 "Consistent with FDA Label" ( CFL ) claims are scientifically appropriate and statistically sound ( SASS ). Lead or serve as the key point of contact on various statistics related initiatives. +

Cross-functional Collaboration :

+ Work closely with Global Value Evidence, Medical Affairs, Market Access, Regulatory, Clinical Management and Global Clinical Development teams to ensure alignment and successful execution of evidence generation strategies. + Provide statistical leadership in preparing evidence for HTA submissions and pricing/reimbursement strategies. + Collaborate with external vendors and partners to ensure the timely, high-quality delivery of statistical analyses and reports. +

Evidence Generation and Statistical Support :

+ Lead the development and execution of statistical analysis plans (SAPs) and ensure the integrity and robustness of statistical analyses for clinical trials and real-world studies. + Lead the a To view full details and how to apply, please login or create a Job Seeker account