Global Medical Affairs Statistical Science Lead Associate Director

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose and Scope:

The Medical Affairs Statistical Science Lead serves as a key quantitative and strategic leader within the global EGAA (Evidence Generation and Advanced Analytics) and Medical Affairs Statistical Science organization, accountable for delivering high quality statistical support to enable global medical affairs evidence generation and decision making across assigned products or disease areas. This role provides scientific leadership in study design, analysis, and interpretation, while collaborating closely with Medical Affairs, HEOR/Market Access, and global evidence teams to ensure rigorous, timely, and decision relevant insights.

Responsibilities and Accountabilities:

• Serve as a primary quantitative partner to Medical Affairs and HEOR/Market Access for assigned therapeutic areas or products across, contributing to evidence strategies and lifecycle evidence planning.
• Provide statistical and analytical leadership for Medical Affairs-led activities, including post approval clinical studies, observational studies, post hoc and exploratory analyses, indirect treatment comparison and secondary publications.
• Translate evidence strategies into executable statistical plans, ensuring scientific rigor and regulatory readiness.
• Lead statistical design, SAP development, analysis, and interpretation for observational studies.
• Conduct and oversee post hoc and exploratory analyses, advanced analytics, and secondary publications, ensuring high scientific integrity, reproducibility, transparent documentation, and alignment with Medical Affairs evidence plans.
• Contribute to HTA and payer evidence packages through robust statistical analyses and appropriate interpretation of results.
• Support post marketing commitments from a statistical perspective, ensuring alignment with prespecified objectives and timelines.
• Provide statistical input into publication strategy and support abstract, poster, and manuscript development.
• Partner closely with Programming, Data Management, Medical Writing, Pharmacovigilance, Regulatory, HEOR/Market Access, and Clinical colleagues to enable end to end evidence generation.
• Collaborate with Medical Affairs Statistical Science teams to ensure consistency with global standards and contribute to broader initiatives as needed.
• Oversee CROs and external statistical partners for assigned studies and analyses, ensuring high quality, on time, and cost effective delivery.
• Apply established best practice standards, tools, and processes for Medical Affairs statistical work.
• Ensure compliance with Astellas policies, documentation standards, and ethical requirements.
• Represent the statistical function in internal scientific forums and contribute to continuous improvement of Medical Affairs statistical practices.
• Represent Astellas externally in regulatory/scientific interactions, international statistical meetings, and industry working groups, contributing to the evolution of methods and strengthening Astellas' leadership in Medical Affairs analytics.