Innovative Statistical Scientist Lead (Director Level)

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

The Statistical Scientist Lead in the Innovative Statistical Science group is a senior expert driving the application of advanced statistical methodologies to optimize clinical trial design and quantitative decision-making. This role provides strategic and technical leadership in applying innovative approaches—such as Bayesian modeling, adaptive designs, and hybrid or external controls—to improve efficiency, scientific rigor, and development impact. A key focus is designing studies and decision frameworks that balance exploration, safety, and speed with scientific rigor to inform go/no-go decisions and accelerate development. Experience in early-phase trials, oncology, rare diseases, or late-phase designs (e.g., seamless Phase II/III, multi-regional trials) is highly valued and reflects the breadth of Astellas’ pipeline and commitment to innovation across therapeutic areas.

This position is expected to be delegator of the head of innovative statistical science internally and externally, develop a reliable network of academics, regulatory experts, and industry peers, and lead the research area as an industry expert.

Essential Job Responsibilities:

1. Innovation and Methodological Excellence

• Provide statistical solutions on statistical designs, statistical analyses, simulation works, and other methodological activities for Phase 1 through Phase 4 studies across multiple therapeutic areas with a good understanding of medical literature, clinical trial, regulatory, and commercial landscape.
• Have expertise in statistical methodology in early-stage designs, including dose optimization, efficacy and safety monitoring, basket trial design, and quantitative decision-making in oncology while keeping balance exploration, safety, and speed with rigor to inform go/no-go criteria.
• Ensure the implementation of statistical and methodological activities in all drug developments and clinical trials.
• Provide the QC of sample size calculation, quantitative decision making (QDM), highly statistical analysis, and simulation work for whole drug developments and clinical trials.
• Have sufficient statistical knowledge, learning novel methodologies, coding skills (R, SAS, etc), and research experience.

1. Academic Activities

• Proceed with multiple research projects, providing impacts in the research area and leading the research area as an industry expert.
• Develop a reliable network of academics, regulatory experts, and industry peers and investigate and share new statistical methodologies.
• Is a member of external industry and professional organizations, takes important roles at academic conferences, is a committee member, organizes programs and sessions, chairs scientific sessions, and makes presentations.
• Constantly publish manuscripts in academic journals.

1. Mentorship and Capability Development

• Mentor statisticians and analytics professionals across QSEG, supporting scientific development.
• Share knowledge, best practices of novel methodology, and internal and external networks.
• Mentor long-term and short-term PhD students and post-doctors through internship programs.
• Contribute to internal training, methodology development, and talent pipeline initiatives.

Qualifications:

Required

• PhD (or MSc with equivalent experience) in Biostatistics, Statistics, or a related quantitative discipline.
• Minimum of 8 years of industry and/or academic experience in clinical development with increasing responsibility and strategic impact.
• Excellence in modern statistical methods in clinical trials, including advanced Bayesian methods, adaptive designs, external control arms, seamless designs, efficacy and safety monitoring, and quantitative decision-making (especially in oncology).
• Strong scientific contributions through publications (at least 10 papers), presentations, and participation in industry/regulatory working groups.
• Strong communication, collaboration, and stakeholder engagement skills across both technical and non-technical audiences.
• Excellence in statistical software (e.g., SAS, R) and familiarity with simulation tools.

Preferred

• Familiarity with AI/ML applications in clinical development.
• Experience working with real-world data sources, including data integration, study design, and interpretation.
• Broad expertise across clinical trial statistics, exploratory statistics, Medical Affairs statistics, biomarker statistics, safety/PV statistics, real-world evidence (RWE) analytics, and statistical programming.
• Good knowledge of medical literature, clinical, regulatory, and commercial landscape.

Salary Range

$170K – $240K (NOTE: Final salary could be more or less, based on experience)

Benefits:

• Medical, Dental and Vision Insurance
• Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
• 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
• Referral bonus program

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