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
- Represent the statistics function in clinical development programs and contribute to strategic planning.
- Oversee statistical deliverables and advise cross-functional teams on data-driven decision-making.
- Support regulatory submissions and interactions from a statistical perspective.
- Monitor emerging methodologies such as RWD and innovative clinical designs and integrate them into development planning.
- Promote continuous learning, knowledge sharing, and innovation within the department.
- Enhance the organization's professional reputation through internal and external engagement activities.
Required Skills and Qualifications
Experience:
- Master's or Ph.D. in Statistics, Biostatistics, or a related field.
- 6+ years of experience as a statistician in clinical development.
- Experience contributing to regulatory submissions and approvals with at least one major authority.
- Proficiency in SAS and/or R, including experience with sample size estimation and simulation tools.
- Knowledge of CDISC standards (SDTM/ADaM).
- Strong communication skills for cross-functional and global collaboration.
Soft Skills:
- Ability to work proactively and independently.
- Strong analytical thinking and problem-solving skills.
- Effective stakeholder communication and coordination abilities.
- Adaptability to evolving statistical methodologies and industry trends.
Language Requirements:
- Japanese: Fluent.
- English: Intermediate to Business level.
Preferred Skills & Qualifications
- Leadership experience managing a statistics or programming team.
- Experience with RWD methodologies.
- 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
- Opportunity to lead statistical strategy in global clinical development.
- Collaborative, international project environment with strong scientific engagement.
- Organization committed to innovation, continuous learning, and professional development.
Don't Miss Out - Apply Now!
