Associate Director, Biostatistics

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women’s health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner.

For more information on SMPA, visit our website  or follow us on Linked In.

The Associate Director, Biostatistics reports to the Vice President, Biostatistics and serves as the statistical lead for one or more clinical development programs. This position provides strategic statistical leadership across clinical development, including development planning, study design, quantitative decision-making, data analysis, regulatory submissions, and external collaborations. The Associate Director partners with cross-functional leaders to ensure that statistical strategies and deliverables are scientifically rigorous, operationally feasible, and aligned with program and regulatory objectives.

• Serve as the biostatistics lead for one or more clinical development programs, providing strategic statistical input into clinical development plans, study designs, operational decisions, decision criteria, and analysis strategies.
• Represent Biostatistics on cross-functional program and study teams and ensure that statistical considerations are incorporated into key development decisions.
• Lead statistical interactions with regulatory authorities, including the planning and preparation of briefing documents, responses to regulatory questions, and discussions of statistical methodology.
• Author or oversee the development and review of statistical sections of protocols, statistical analysis plans, regulatory submissions, publications, and other scientific documents.
• Provide statistical interpretation of study results, communicate benefit-risk considerations, and support data-driven program decisions.
• Identify statistical, operational, and regulatory risks and recommend practical mitigation strategies.
• Oversee CRO and external vendor statistical activities, including scope definition, quality review, timelines, and delivery of statistical outputs.
• Provide technical leadership, coaching, and mentorship to statisticians and statistical programmers, as appropriate.
• Evaluate and apply innovative statistical methods, including Bayesian approaches, adaptive or complex trial designs, and quantitative decision-making methods when appropriate.
• Contribute to departmental standards, process improvements, statistical governance, and capability development.

• Broad and current knowledge of statistical principles, clinical-trial methodology, and their application throughout drug development.
• Strong understanding of applicable regulatory guidance, including ICH guidelines and expectations of FDA, EMA, PMDA, and other health authorities.
• Knowledge of relevant industry standards, including CDISC standards.
• Experience with complex trial designs, Bayesian methods, or innovative statistical approaches is preferred.
• Proficiency in statistical computing using SAS and R.
• Ability to communicate complex statistical concepts and recommendations clearly to technical and non-technical audiences.
• Demonstrated ability to provide strategic leadership, influence cross-functional decisions, and manage multiple priorities in a fast-paced environment.
• Proven ability to collaborate effectively across functions and communicate recommendations to senior leadership.

• PhD in Statistics, Biostatistics,…