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.

This position reports to the Executive Director of Biostatistics and is an integral part of the oncology biostatistics team. The team supports all statistical deliverables within SMPA's oncology clinical development. The role involves leading statistical activities for oncology clinical projects and ensuring effective collaboration and alignment with cross‑functional teams.

• Lead Statistical Efforts
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  Serve as the biostatistics lead for one or more studies within a project team, offering expertise in study design, operations, decision rules, and analysis planning.
• Develop and Oversee Statistical Documentation
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  Author and oversee the production of statistical sections of protocols and analysis plans, and contribute to the statistical sections of publications across multiple clinical projects.
• Mentor and Manage Team Members
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  Provide coaching and management for junior biostatisticians, fostering their professional development and ensuring high‑quality output.
• Oversee CRO Statistical Activities
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  Plan, manage, and supervise the statistical activities conducted by Contract Research Organizations (CROs) to ensure alignment with project objectives and standards.
• Provide Technical Guidance
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  Offer guidance to junior statisticians and statistical programmers on developing SDTM/ADaM datasets and TLF specifications, and perform quality checks on statistical programming efforts as needed.

• Leadership and Management
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  Demonstrated capability to lead and mentor teams, manage multiple projects simultaneously, and drive results in a fast‑paced environment.
• Communication Skills
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  Strong written and verbal communication skills with the ability to present complex statistical concepts to both technical and non‑technical audiences.
• Collaboration
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  Proven ability to work effectively as part of a cross‑functional team, fostering a positive and productive work environment.
• Problem‑Solving
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  Strong analytical and problem‑solving skills with the ability to make strategic decisions based on data‑driven insights.
• Project Management
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  Ability to plan, organize, and manage biostatistical aspects of projects from start to finish.
• Statistical Expertise
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  In‑depth knowledge of statistical methods and their application in oncology clinical trials, including experience with Bayesian modeling, complex trial designs, and analysis techniques.
• Software Proficiency
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  Proficient in statistical programming languages and software, such as SAS and R, with the ability to guide data analysis and interpretation.
• Regulatory Knowledge
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  Familiarity with regulatory guidelines and standards (e.g., FDA, EMA, ICH) relevant to biostatistics and clinical trials.
• Data Standards
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  Experience with data standards such as CDISC SDTM and ADaM, including overseeing the development and quality control of specifications.
• Quality Control
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  Strong attention to detail and commitment to ensuring the accuracy and integrity of statistical analyses and programming outputs.

• PhD or MS in statistics or biostatistics. PhD is preferred.
• Minimum 5‑year (for PhD) or 8‑year (for MS) experience in clinical trials is required.
• Broad and thorough understanding of statistical principles, up‑to‑date statistical design and methodologies, and their applications in clinical trials.
• Strong statistical leadership in a multi‑functional project environment: able to manage many projects simultaneously as well as conflicting priorities.
• Effective writing and communication skills: able to author various statistical documents; able to explain to team clearly and help team understand complex statistical design, methodology, decision rule, analysis plan and statistical report.
• Experience with Bayesian modeling and analysis.
• Experienced with SAS programming, R programming and other statistical software.
• Experience with AI or agentic AI in statistical reporting is a plus.
• People management is a plus.