Global Medical Affairs Statistical Science Lead (Associate Director)
Astellas Pharma
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Benefits offered by this job
Job summary
Astellas Pharma in Northbrook, IL is seeking a Medical Affairs Statistical Science Lead to provide strategic statistical leadership across assigned products and evidence generation initiatives, partnering with Medical Affairs, HEOR/Market Access, and global teams.
You will design observational studies, lead SAPs, oversee CROs, and translate evidence strategies into rigorous analyses, while ensuring regulatory readiness and timely delivery in a highly matrixed, international environment.
Qualifications
- PhD/MS in Biostatistics or related field.
- 7+ years (10+ for MS) of relevant experience.
- Lead statistician on programs/studies/therapeutic areas.
- Observational/RWE study design and analysis.
- SAS proficiency; R preferred.
- Experience in matrixed, cross-functional, international environments.
- Strong written and verbal English communication.
Responsibilities
- Provide statistical leadership for Medical Affairs activities.
- Design and analyze observational studies and post-approval analyses.
- Translate evidence strategies into executable statistical plans.
- Oversee SAP development, analysis, and interpretation.
- Collaborate with cross-functional teams and external partners to enable end-to-end evidence generation.
Skills
Education
Tools
Job description
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.
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.
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.
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.
- 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.
- 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.
- 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.
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.
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Innovation, Integrity and Impact sit at the heart of what we do.
We come together as One Astellas , working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.
$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)
- 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
Astellas is committed to equality of opportunity in all aspects of employment.
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