Astellas Pharma
Clinical Modeling & Analytics Innovation Lead
Astellas Pharma, Northbrook, Illinois, us, 60065
Overview
Clinical Modeling & Analytics Innovation Lead at Astellas Pharma. Join to apply for the Clinical Modeling & Analytics Innovation Lead role at Astellas Pharma. 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. 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. For more information, please visit our website at www.astellas.com. Purpose and scope: The Clinical Modeling, Analytics & Operational Excellence team is a high-impact innovation team applying advanced analytics, real-world data, modeling & simulation, and AI/ML to solve critical challenges in clinical development. The 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 role shapes the future of data-driven clinical development by pioneering innovative solutions at the intersection of AI/ML, analytics, modeling and simulation. The position partners with clinical, biostatistics, real-world data, clinical operations, and digital/IT teams to improve feasibility assessments, enhance enrollment forecast, deepen data exploration and optimize trial decision-making. The role also drives adoption of emerging technologies to transform clinical trial strategy and execution.
Essential Responsibilities
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 critical clinical development tasks (e.g., site feasibility, patient enrollment, endpoint assessment, protocol optimization, operational risk estimation, and trial outcome prediction). 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 for specific business areas and contributes to portfolio-level strategy and capabilities. 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 establishes thought leadership through publications, presentations, and collaborations. Mentors junior team members, fosters internal quantitative excellence, shares best practices, and contributes to a 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 in 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 with diverse data sources (clinical trials, RWD, industry benchmark data) and data standards (CDISC, OMOP, CTMS) 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 partnerships. Preferred: Experience with development and deployment of generative AI solutions (LLMs or foundational models), digital twins, or medical imaging analytics. Recognized contributions and quantitative expertise in advanced analytics, modeling & simulation and AI/ML with publications and presentations. Experience with MLOps and workflow development within cloud platforms (Azure, AWS, GCP).
Working Environment
Hybrid work arrangement with flexibility to work from home where allowed by company policy.
Benefits
Medical, Dental and Vision Insurance Generous Paid Time Off options, including vacation, sick time, holidays, and seasonal breaks 401(k) match and annual company contribution Company-paid life insurance Annual Corporate Bonus and Quarterly Incentive for eligible positions Long Term Incentive Plan for eligible positions Referral bonus program
Equal Opportunity
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
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Clinical Modeling & Analytics Innovation Lead at Astellas Pharma. Join to apply for the Clinical Modeling & Analytics Innovation Lead role at Astellas Pharma. 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. 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. For more information, please visit our website at www.astellas.com. Purpose and scope: The Clinical Modeling, Analytics & Operational Excellence team is a high-impact innovation team applying advanced analytics, real-world data, modeling & simulation, and AI/ML to solve critical challenges in clinical development. The 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 role shapes the future of data-driven clinical development by pioneering innovative solutions at the intersection of AI/ML, analytics, modeling and simulation. The position partners with clinical, biostatistics, real-world data, clinical operations, and digital/IT teams to improve feasibility assessments, enhance enrollment forecast, deepen data exploration and optimize trial decision-making. The role also drives adoption of emerging technologies to transform clinical trial strategy and execution.
Essential Responsibilities
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 critical clinical development tasks (e.g., site feasibility, patient enrollment, endpoint assessment, protocol optimization, operational risk estimation, and trial outcome prediction). 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 for specific business areas and contributes to portfolio-level strategy and capabilities. 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 establishes thought leadership through publications, presentations, and collaborations. Mentors junior team members, fosters internal quantitative excellence, shares best practices, and contributes to a 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 in 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 with diverse data sources (clinical trials, RWD, industry benchmark data) and data standards (CDISC, OMOP, CTMS) 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 partnerships. Preferred: Experience with development and deployment of generative AI solutions (LLMs or foundational models), digital twins, or medical imaging analytics. Recognized contributions and quantitative expertise in advanced analytics, modeling & simulation and AI/ML with publications and presentations. Experience with MLOps and workflow development within cloud platforms (Azure, AWS, GCP).
Working Environment
Hybrid work arrangement with flexibility to work from home where allowed by company policy.
Benefits
Medical, Dental and Vision Insurance Generous Paid Time Off options, including vacation, sick time, holidays, and seasonal breaks 401(k) match and annual company contribution Company-paid life insurance Annual Corporate Bonus and Quarterly Incentive for eligible positions Long Term Incentive Plan for eligible positions Referral bonus program
Equal Opportunity
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans.
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