Head of Evidence Generation & Advance Analytics

Job Description

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:

This position will lead the Evidence Generation Advanced Analytics team, driving statistical and epidemiology strategy for real-world evidence (RWE) generation and advanced analytics across one or more Therapeutic Areas (TAs) in Quantitative Sciences Evidence Generation department (QSEG). This team, which includes epidemiology experts, is responsible for leveraging RWE, observational studies, and advanced analytics to generate insights that inform clinical development, regulatory strategies, and post-approval evidence needs. The VP will lead the integration of epidemiological insights, ensuring a deep understanding of disease pathways, natural history, and patient populations, which will be critical for informing both early and late-phase clinical development. Additionally, the VP will oversee methodological innovation in RWE, modelling, simulation, machine learning teams from clinical trials and drug development process, and life cycle management, including medical affairs statistics to support post-approval data generation.

A key aspect of this role is collaborating with the clinical statistical team, ensuring that real-world data complements clinical trials by supporting external control arms, refining patient populations, and strengthening evidence packages. The VP will partner with key stakeholders in development, pharmacovigilance, clinical operations, medical affairs, and commercial strategy to drive an integrated approach to portfolio decision-making. Furthermore, this role will provide strategic leadership in due diligence assessments and business development efforts, ensuring a global perspective through collaboration with Japan-Asia statistics.

This role will report to the SVP, Global Head of QSEQ, and as a member of QSEQ leadership team. Direct supervision of 4-8 staff; indirect supervision of approx. 60 individuals globally.

Essential Job Responsibilities:

• Contribute to the development and implementation of 1-3 year Biostatistics objectives and plans, leading at least one significant strategic initiative.
• Provide quantitative leadership in due diligence assessments for business development and licensing opportunities, evaluating external assets for real-world data feasibility and validation. Identify strategic partnerships to enhance RWE and advanced analytics capabilities.
• Lead the Evidence Generation Advanced Analytics team, including epidemiology experts, ensuring disease area expertise and integration of RWE, observational studies, and advanced analytics into drug development strategies.
• Collaborate with Medical TAH and staff to ensure therapeutic area-specific expertise, strategic statistical input in project governance, and alignment of quantitative approaches in portfolio decisions.
• Support clinical development, regulatory, pharmacovigilance, and medical affairs by integrating RWE into clinical plans, protocols, regulatory submissions, and publications.
• Ensure alignment across development functions, including TAHs, Medical Science Heads, CPED, Pharmacovigilance, and Regulatory Affairs, optimizing data strategies across clinical and observational studies.
• Work with head of COQS Business and Operations and head of Clinical Programming to define and manage functional service provider (FSP) and vendor support, ensuring cost-effective and high-quality statistical services.
• Oversee the timely completion of Biostatistics deliverables across all phases of clinical development, ensuring adherence to quality and budget. Provide strategic oversight to Global Statistical Leads in executing study deliverables.
• Drive organizational excellence, ensuring statistical methodologies are aligned with external innovations and evolving industry standards. Lead improvements in statistical competencies and methodologies for emerging therapeutic areas and evolving regulatory landscapes.
• Recruit, develop, and manage high-performing talent, providing leadership, technical guidance, and mentorship to strengthen the Evidence Generation Advanced Analytics team. Ensure continuous training and knowledge-sharing across Biostatistics.
• Lead the development of TA-specific statistical standards, ensuring best practices in data structures, definitions, methodologies, and data presentation.
• Provide statistical oversight for regulatory engagements, leading discussions with regulatory authorities, key opinion leaders, and industry groups.
• Ensure that all programs within the TA have robust quantitative approaches, clearly communicated to leadership for high-quality portfolio decisions.
• Partner with clinical statistical teams to ensure that RWE and clinical trial data are optimally combined to support external validation, external control arms, and refined patient populations.
• Lead the research and integration of new disease areas, ensuring a deep understanding of endpoints, regulatory requirements, and available data sources to guide efficient development strategies through RWE strategy.
• Lead team to collaborate with clinical stats team to develop external control arms, leveraging RWE to supplement or replace traditional clinical trial elements where appropriate.
• Oversee safety signal detection and benefit-risk assessments through real-world analytics, supporting pharmacovigilance strategies.
• Guide natural history studies and patient journey analyses, informing early development decision-making.
• Engage with regulatory agencies and external experts to shape the acceptance and use of RWE in regulatory decision-making.
• Represent the organization in industry working groups, professional societies, and conferences, influencing the broader RWE landscape.
• Strengthen external collaborations with academic institutions, data vendors, and technology partners, enhancing RWE capabilities and ensuring access to high-quality real-world data sources.
• Lead medical affairs statistics in post-approval evidence generation, ensuring long-term product value demonstration.
• Collaborate with commercial teams to integrate RWE insights into health economics and market access strategies, strengthening product positioning.
• Ensure process efficiency and continuous improvement across QSEG, maintaining up-to-date, scalable methodologies to support RWE and Biostatistics functions.

Requirements

Qualifications:

Required

• MS, preferably PhD or equivalent in Biostatistics, Epidemiology, Data Science, or a related quantitative field. minimum of approximately 15+ years of experience in pharmaceutical, biotech, or healthcare industries, with leadership roles in RWE, epidemiology, or biostatistics.
• Proven track record of leading global teams and driving strategic initiatives in evidence generation and advanced analytics.
• Deep expertise in real-world evidence (RWE), epidemiology, and advanced analytics, including AI/ML applications.
• Strong background in study design, causal inference, and statistical modeling for observational research.
• Knowledge of regulatory guidelines (FDA, EMA, PMDA) on RWE, external control arms, and benefit-risk assessment.
• Experience with HTA requirements, PRO submissions, and post-approval data strategies.
• Experience in all aspects of statistics for clinical trials, and in working as a member of a project team including design of clinical studies and contribution to Clinical Development Plans
• Proven ability to manage managers
• Demonstrated ability to lead independently
• Excellent understanding of the various functions and expert groups contributing to Drug Development
• Solid knowledge of SAS and other statistical tools
• Demonstrated ability to translate strategic plans into goals and objectives for their own function
• Demonstrated leadership skills and ability to effectively prioritize own group's activities for development projects and clinical trials
• Proven ability to establish operating guidelines and procedures, preferably in a global setting
• Demonstrated ability to successfully identify and lead global process or system improvement initiatives
• Strong communication and stakeholder engagement skills, with the ability to influence at senior leadership levels and represent the organization in external forums.

Preferred:

• Extensive pharmaceutical, biotech, or healthcare industry experience leading real-world evidence generation, epidemiology, or biostatistics efforts.
• Active participation in industry working groups, professional societies (ISPOR, ISPE, DIA, PSI, ASA), and academic collaborations.
• Strong expertise in regulatory-grade RWE methodologies, including causal inference, advanced statistical modelling, and machine learning approaches.
• Demonstrated ability to partner with clinical statistics teams, ensuring synergistic integration of RWE and clinical trial data to optimize development and regulatory strategies.
• Experience leading interactions with global regulatory agencies (FDA, EMA, PMDA, etc.) on RWE-related topics, including regulatory submissions and post-approval commitments.
• Strong leadership experience, with a history of building and developing high-performing teams in RWE, epidemiology, or advanced analytics.
• Proven ability to collaborate cross-functionally with development, regulatory, medical affairs, pharmacovigilance, and commercial teams to support portfolio strategy and decision-making.
• Experience leading RWE-driven regulatory submissions or working directly on regulatory RWE guideline development.
• Expertise in novel data sources (e.g., real-world claims, EMR, registries, wearable/remote monitoring data) and their applications in drug development and post-market surveillance.
• Deep understanding of disease pathways, natural history studies, and unmet medical needs, particularly in complex and evolving therapeutic areas.
• Experience working with FSP/vendor management to optimize real-world data analytics and outsourced statistical services.
• Active participation in industry groups, external collaborations, or consortia focused on RWE and real-world data methodologies.
• Familiarity with health economics, market access, and commercial analytics, leveraging RWE for payer engagement and product differentiation.
• Strong background in advanced analytics, AI/ML, and real-world predictive modelling for trial optimization and precision medicine applications.
• Proven track record in designing and executing RWE studies, including observational research, external control arms, safety signal detection, and benefit-risk assessment.
• Excellent communication and presentation skills to influence senior leadership and external stakeholders.
• Ability to translate complex quantitative insights into actionable business strategies for clinical and commercial teams.

Salary Range

$350K - $425K (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