Join a global biopharmaceutical organization as a Biostatistics Lead, driving statistical strategy and execution across clinical development programs. In this high-impact role, you will partner with global teams to shape study design, guide data-driven decisions, and support high-quality regulatory submissions. You will contribute to innovative statistical methodologies, mentor teams, and strengthen the organization's scientific reputation through collaboration and technical excellence.
Key Responsibilities
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Represent the statistics function in clinical development programs and contribute to strategic planning.
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Oversee statistical deliverables and advise cross-functional teams on data-driven decision-making.
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Support regulatory submissions and interactions from a statistical perspective.
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Monitor emerging methodologies such as RWD and innovative clinical designs and integrate them into development planning.
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Promote continuous learning, knowledge sharing, and innovation within the department.
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Enhance the organization's professional reputation through internal and external engagement activities.
Required Skills and Qualifications
Experience:
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Master's or Ph.D. in Statistics, Biostatistics, or a related field.
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6+ years of experience as a statistician in clinical development.
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Experience contributing to regulatory submissions and approvals with at least one major authority.
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Proficiency in SAS and/or R, including experience with sample size estimation and simulation tools.
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Knowledge of CDISC standards (SDTM/ADaM).
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Strong communication skills for cross-functional and global collaboration.
Soft Skills:
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Ability to work proactively and independently.
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Strong analytical thinking and problem-solving skills.
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Effective stakeholder communication and coordination abilities.
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Adaptability to evolving statistical methodologies and industry trends.
Language Requirements:
Preferred Skills & Qualifications
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Leadership experience managing a statistics or programming team.
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Experience with RWD methodologies.
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Familiarity with innovative clinical trial designs.
About the Company
Our client is a global biopharmaceutical organization dedicated to delivering patient value through scientific innovation. The Japan team works closely with global counterparts to execute high-quality clinical development programs and contribute strategic insights that support global approvals.
Why You'll Love Working Here
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Opportunity to lead statistical strategy in global clinical development.
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Collaborative, international project environment with strong scientific engagement.
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Organization committed to innovation, continuous learning, and professional development.
Don't Miss Out - Apply Now!
