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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 Clinical Modeling, Analytics & Operational Excellence team is a high-impact innovation team that applies advanced analytics, real-world data, modeling & simulation, and AI/ML to solve critical challenges in clinical development. This team designs and implements predictive models for patient recruitment and retention, optimizes trial feasibility and site selection, assesses novel clinical endpoints, simulates study outcomes to guide protocol design, and develops innovative operational strategies to reduce execution risk and accelerate timelines.

The Clinical Modeling & Analytics Innovation Lead will shape the future of data-driven clinical development by pioneering innovative solutions at the intersection of AI/ML, advanced analytics, modeling and simulation. The position partners closely with colleagues across clinical, biostatistics, real-world data, clinical operations, and digital/IT to improve feasibility assessments, enhance enrollment forecast, deepen data exploration and optimize trial decision-makings. In addition, the Clinical Modeling & Analytics Innovation Lead serves as a strategic partner and innovator, driving adoption of emerging technologies (e.g., generative foundational models, digital twins, and advanced imaging analytics) to transform clinical trial strategy and execution.

Essential Job Responsibilities:

The Clinical Modeling & Analytics Innovation Lead

+ Leads cross-functional initiatives applying clinical modeling & simulation, advanced analytics, and AI/ML to trial design, feasibility, and execution optimization.

+ Develops advanced simulation and predictive models supporting a variety of critical clinical development tasks, e.g., site feasibility, patient enrollment, endpoint assessment, protocol optimization, operational risk estimation and trial outcome prediction etc.

+ Partners with medical, biostatistics, real-world data, and operational teams to embed modeling & analytics insights into protocol development, portfolio planning and decision-making.

+ Leads the development of clinical modeling & data strategy and roadmap dedicated to specific business areas, and contribute to portfolio-level clinical modeling strategy and capabilities accelerating and optimizing clinical development.

+ Proposes and pilots innovative solutions (e.g., digital twins, trial emulation, hybrid designs, real-time patient targeting) to support trial planning, optimization and execution.

+ Represents the organization in external scientific and regulatory forums, and establish thought leadership through publications, presentations, and industry collaborations.

+ Mentors junior team members, foster internal quantitative excellence, share best practices and contribute to the culture of innovation, collaboration, and accountability for results **.**

Qualifications

Required:

+ Advanced degrees in Statistics/Biostatistics, Data Science, Artificial Intelligence, Machine Learning, Epidemiology, Computational Biology, Informatics or related quantitative disciplines.

+ PhD with minimum 6+ years of experience or MS with minimum 9+ years of experience in pharma/biotech, CROs or healthcare settings.

+ Deep expertise and strong hand-on experience of modeling and simulation techniques and AI/ML in predictive modeling, trial simulation, or trial operational analytics.

+ Proficiency in R, Python, SAS, and relevant simulation platforms.

+ Experience and knowledge with various data sources (i.e., clinical trials, RWD, industry benchmark data), and relevant data standards (CDISC, OMOP, CTMS etc.) in clinical development and operations.

+ Track record of leveraging advanced analytics, modeling and AI/ML to drive measurable impacts in drug R&D and life sciences

+ Strong communication skills and experience to develop collaboration and partnership

Preferred:

+ Experience with development and deployment of generative AI solutions (i.e., LLMs or foundational models), digital twins or medical imaging analytics etc.

+ Recognized contributions and quantitative expertise in advanced analytics, modeling & simulation and AI/ML, i.e., with top-tier publications and presentations

+ Experience with MLOps and workflow development within cloud platforms (Azure, AWS, GCP etc.)

Working Environment:

+ 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.

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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Category Quantitative Sciences & Evidence Generation

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

EOE including Disability/Protected Veterans