Manager, Statistical Programmer, Statistical and Quantitative Sciences Japan

必須

• Bachelor’s degree or higher in information science, statistics, or a related field.
• Operational experience in pharmaceutical drug development, including substantial direct exposure to clinical development.
• Strong expertise or experience in the pharmaceutical industry and statistical programming.
• Advanced SAS programming skills, including the ability to develop and execute appropriate programming code.
• Knowledge of applicable regulatory standards and guidance, including the ability to apply relevant CDISC standards to statistical deliverables.
• Understanding of regulatory guidance related to statistical programming, analysis environments, and electronic data submissions.
• Written and verbal English communication skills.
• Strong interpersonal and communication skills to build collaborative relationships with stakeholders, including global colleagues.

使用ツール

About the Role

• In this role, you will guide statistical programming for clinical trials from Phase I through Phase IV, integrated analyses, post-marketing surveillance, and company-sponsored medical affairs studies. You will contribute to Japan regulatory submissions by supporting electronic data submissions in CDISC-compliant formats, including agency consultations, inspection readiness, and responses to agency inquiries. As part of Statistical and Quantitative Sciences in Japan, you will work with global programming colleagues to advance standards for data and tables, listings, and figures. You will also help improve the business by proposing and implementing innovative technologies and tools, including advanced SAS macros, R, Python, artificial intelligence, and machine learning. Your work will support study delivery, regulatory readiness, and more consistent programming practices. You will collaborate with global colleagues and study stakeholders, manage assigned study budgets and schedules, and contribute to process improvement and knowledge sharing.

How You Will Contribute

• Lead assigned study programming** by coordinating statistical programming deliverables across one or more projects.
• Manage study budgets and schedules** for assigned studies and electronic data submissions for Japan regulatory filings.
• Shape submission strategies** by planning CDISC-compliant deliverables and developing mitigation plans.
• Collaborate with global colleagues** to align programming approaches and contribute to standardization of data and tables, listings, and figures.
• Engage with study stakeholders and agencies** to discuss study matters and support appropriate handling of questions and responses.
• Improve programming processes** by contributing to or leading initiatives that enhance team and organizational ways of working.
• Advance innovative solutions** by proposing and implementing appropriate technologies and tools for business improvement.
• Share expertise and guide colleagues** by supporting junior staff and contributing to internal and external discussions on relevant topics.