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.

Required Qualifications:

• PhD or M.S in Biostatistics, Statistics or related scientific field
• 7+ years (10+ years for MS) of experience applying statistical methods in Pharma, CRO, academia, or healthcare research.
• Strong knowledge of statistical methods and industry practices related to clinical, post approval, and real-world data analysis.
• Experience serving as a lead statistician or statistical point of contact for one or more programs, studies, or therapeutic areas.
• Experience with observational/RWE study design and analysis.
• Proficiency in SAS; working knowledge of R preferred.
• Experience working in matrixed, cross functional, and international environments.
• Strong written and verbal English communication skills.

Preferred Qualifications:

• Deep experience with global evidence generation, post-marketing requirements, or RWE environments.
• Experience with evidence generation strategies and market access requirements, including familiarity with regional HTA processes, payer evidence expectations, and cross-market evidence development.
• Experience representing statistical functions in discussions with regulatory authorities or HTA bodies.
• Track record of scientific publications or congress presentations.
• Familiarity with emerging data sources (e.g., real world databases, digital endpoints) and advanced analytics methods.

Location and Working Environment

This position is based in Northbrook, IL. Remote work from anywhere in the US is available.

At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.

This position is a global role with strong interaction with various disciplines and international stakeholders

• Highly matrixed environment requiring cross-regional coordination.
• Frequent interaction with senior leadership and governance bodies.
• Collaboration across EU, US, and Japan time zones.

Salary Range

$144,060 - $205,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations)

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company paid life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positions
• Referral bonus program

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