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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 Head of Clinical Modeling, Analytics & Operational Excellence is a senior leader within the Statistical innovation organization at Astellas. This role is responsible for building and leading a high-impact innovation team that leverages advanced analytics, real-world data (RWD), modeling & simulation, AI/ML to optimize clinical trial design, feasibility, and execution across the portfolio.

It is a forward-looking, enabling function focused on strategic trial optimization, clinical operational innovation, and data-driven decision-making. It complements the work of Biostatistics by addressing questions of feasibility, performance prediction, execution risk, and innovation that lie outside of hypothesis testing and regulatory deliverables.

This role will shape the vision, build internal capabilities, lead innovation projects, and influence key clinical development strategies across Astellas’ pipeline.

The position receives for resolution unique, far-reaching, and previously unresolved problems. It works independently and involves the right level of participants as needed within or outside R&D.

Essential Job Responsibilities:

Strategic Leadership & Team Building

+ Define and execute the long-term vision for clinical trial modeling, simulation, and operational analytics.

+ Build and lead a team focused on enabling smarter trial design and execution through innovation and advanced technologies.

+ Serve as a senior strategic partner to Biostatistics, Clinical Operations, RWE, and Medical Affairs functions.

+ Act as a change agent within Astellas to promote modern, evidence-driven approaches to trial planning and feasibility.

+ Champion and oversee innovation projects, collaboration with Digital X team, leveraging AI/ML, digital twins, hybrid trial models, and other advanced technologies to improve speed, precision, and insight generation in clinical development.

+ Pilot and scale digital innovation that enhances feasibility assessment, trial simulation, participant targeting, or trial design adaptation.

+ Develop and maintain a robust methodology framework and innovation roadmap that keeps Astellas on the leading edge of data-enabled development.

+ Collaborating with digital x team to build reusable tools and platforms to support enrollment forecasting, trial simulation, and execution decision support across clinical programs.

Modeling & Simulation for Trial Design Enablement

+ Guide the application of simulation-based techniques to evaluate trial design options, stress-test assumptions, and estimate probability of technical success.

+ Support design optimization through scenario modeling (e.g., sample size, drop-out rate, event timing, adaptive design impact), without duplicating Biostatistics’ role in inferential calculations or regulatory submissions.

+ Collaborate with study teams during protocol development to incorporate feasibility, diversity, and operational insights through predictive modeling.

+ Lead the development of predictive models for enrollment, site activation, drug supply needs, and execution risk, using RWD, historical trials, and real-time data.

+ Monitor trial performance during execution, identify deviations from plan, and proactively propose mitigation strategies (e.g., site/country reallocation, recruitment interventions, protocol amendments).

Before Trial Initiation

+ Advise project teams and statistical leads on ways to optimize trial design from an operational point of view while still meeting regulatory authority requirements.

+ Support the assessment of protocol complexity and model the impact of various options on trial start-up and conduct.

+ Simulate/model multiple enrollment scenarios using state-of-the-art methodology and a combination of industry, RWD, and in-house data in order to accurately plan, manage, and forecast worldwide clinical trial patient enrollment.

+ Compare and optimize the country/site allocation strategies to ensure the successful execution of the diversity plan.

+ Minimize the total cost of the trial and optimize the needs in terms of drug supply.

+ Build plan comparisons to industry benchmarks and pressure-test proposed CRO enrollment plans (if applicable).

+ Model the total expected duration of the trial based on enrollment scenarios, projections of patient retention, and predictions of the timing of the event of interest (for event-driven trials).

+ During trial conduct

+ Pro-actively identify and neutralize issues; compare real-time forecasts and performance updates to their approved plans, diagnose the root cause of enrollment delays, identify country- or site-specific issues

+ Constantly collect and analyze real-time performance metrics and pro-actively reforecast trial timelines and cost

+ Refine models and develop rescue strategies when necessary, including the addition and reallocation of cohorts and sites, modifications to study design, or changes to expected start-up and enrollment variables.

Communication & External Leadership & Scientific Engagement

+ Presents and defends complex statistical solutions to internal governance committees, key stakeholders, or regulatory bodies in a compelling and impactful way

+ Stays at the cutting edge of methodology development in statistics, regulatory guidelines, and industry trends in clinical trial operational excellence, and signals relevant developments in a timely manner for the company.

+ As a leader of external industry or professional organizations, the position develops and maintains relationships with leading academic institutions and key statistical opinion leaders and actively participates in professional association activities to support the branding of Astellas

+ Demonstrates an in-depth understanding of Astellas’ priorities, and uses the position to advance Astellas’ mission through high quality statistical work

+ Is exceptionally effective in ensuring that Astellas stays at the forefront of recruitment, training, professional development and retention of statistical personnel.

+ Represent Astellas in industry consortia, professional organizations, and scientific forums to shape the future of trial modeling and analytics.

+ Monitor evolving regulatory expectations and methodological developments related to trial simulation, AI/ML, and data integration in clinical development.

Qualifications:

Required

+ PhD (or equivalent) in Biostatistics, Computational Science, Data Science, Epidemiology, or a related quantitative discipline.

+ 12+ years (or 15+ for MSc) of experience in clinical development, with significant expertise in trial simulation, predictive analytics, operational modeling, or data-enabled innovation.

+ Proven ability to lead cross-functional teams and innovation programs in a global matrix organization.

+ Advanced knowledge of predictive modeling, machine learning, trial feasibility, and real-world data science.

+ Strong proficiency in tools and platforms such as R, Python, SAS, and simulation engines.

+ Excellent communication, collaboration, and stakeholder engagement skills.

+ Clear understanding of role boundaries between innovation/enablement functions and traditional biostatistics teams.

+ Understand Real World Evidence and Machine Learning.

+ Broad experience in multiple indications and Primary Focus, has supported drug development programs at different stages.

Preferred:

+ Experience applying AI/ML, digital twins, or advanced analytics to clinical research questions.

+ Demonstrated success in building and scaling new capabilities or scientific teams.

+ Active engagement with industry collaborations, academic groups, or regulatory science initiatives.

+ Broad exposure across multiple therapeutic areas and development phases.

Salary Range

$200K – $275K (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

\#LI-SS

Category Quantitative Sciences & Evidence Generation

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans