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 . 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 Global Statistical Lead (GSTATL) for Solid Tumor Oncology is a compound level leader within the Quantitative Science & Evidence Generation (QSEG) organization, accountable for driving the statistical and analytical strategy for a compound or indication across its full development lifecycle. This position leads a cross-functional, integrated quantitative team supporting evidence generation and decision-making, with responsibility spanning clinical trial statistics, exploratory statistics, medical affairs statistics, real-world evidence (RWE), safety/pharmacovigilance (PV) statistics, statistical programming, biomarker statistics, and advanced analytics. The role ensures consistency and scientific excellence across studies, indications, and evidence types-while enabling innovation in statistical methodology, clinical development optimization, and external engagement. The GSTATL plays a key role in regulatory and payer strategy, as well as internal governance and portfolio planning for solid tumor assets. **Responsibilities and Accountabilities:** Strategic Statistical Leadership + Serve as the compound-level statistical lead for solid tumor oncology, responsible for end-to-end quantitative strategy supporting clinical development, evidence generation, and regulatory/payer interactions. + Lead development of integrated statistical strategies across all relevant study types and functions (e.g., e.g., phase 1b/2 signal-seeking, pivotal, exploratory, RWE, post-marketing). + Align statistical and analytical approaches with the target product profile (TPP), development strategy, and external evidence needs. Cross-Functional Quantitative Team Leadership + Lead and coordinate statistical and analytics contributions from a broad QSEG team, including: + Clinical trial biostatisticians + Exploratory oncology statisticians (e.g., tumor burden modeling, subgroup/signal detection) + Medical Affairs statisticians + Statistical programmers + Biomarker/statistical genetics experts in oncology + RWE analysts/statistical epidemiologists + Safety/PV statisticians + Advanced analytics and modeling specialists + Ensure scientific alignment, quality, and integration across all statistical contributions at the compound level. Regulatory and HTA Engagement + Represent Astellas on all statistical matters in global regulatory interactions (e.g., FDA, EMA, PMDA). + Guide preparation of statistical content for regulatory submissions, briefing packages, and health technology assessment (HTA) dossiers. + Lead the development of statistical components of payer evidence strategies, including indirect comparisons and external control methodologies. Innovation and Methodological Excellence + Champion the use of oncology-appropriate innovations, including Bayesian designs, adaptive trial designs, external controls, tumor-agnostic approaches, and AI/ML tools to enhance study design and signal detection. + Promote exploratory data analysis, modeling, and simulation to support rapid development decisions in Solid Tumor trials. + Integrate clinical, biomarker, safety, and real-world evidence to drive cohesive, data-driven development and access strategies. Mentorship and Capability Development + Mentor statisticians and analytics professionals across QSEG, supporting both scientific development and career growth. + Share knowledge and best practices across study teams and therapeutic areas. + Contribute to internal training, methodology development, and talent pipeline initiatives. Governance and Cross-Functional Influence + Participate in global asset governance and development team meetings, influencing decisions with rigorous statistical insight. + Collaborate with Clinical Development, Medical Affairs, Regulatory, Market Access, and Commercial to ensure alignment on evidence planning. + Lead or contribute to internal initiatives, including standardization efforts, methodology forums, and innovation networks. **Qualifications:** **Required** + PhD (or MSc with equivalent experience) in Biostatistics, Statistics, or a related quantitative discipline. + Minimum of 10 years of experience in oncology clinical development, with proven leadership in statistical strategy and regulatory submissions. + Demonstrated experience leading statistical contributions at the compound level, including regulatory engagement and cross-functional integration. + Broad expertise across clinical trial design, exploratory oncology analytics, biomarker evaluation, RWE, and post-marketing study support. + Broad expertise across clinical trial statistics, exploratory statistics, Medical Affairs statistics, biomarker statistics, safety/PV statistics, real-world evidence (RWE) analytics, and statistical programming. + Strong understanding of the drug development lifecycle, regulatory requirements, and evidence generation for both approval and market access. + Ability to lead and influence cross-functional, global teams within a matrix environment. + Strong communication, collaboration, and stakeholder engagement skills across both technical and non-technical audiences. + Proficiency in statistical software (e.g., SAS, R) and familiarity with simulation tools and modern statistical methods. **Preferred:** + Prior experience in oncology or other complex therapeutic areas with evolving clinical and regulatory landscapes. + Familiarity with Bayesian methods, adaptive designs, external control arms, and AI/ML applications in clinical development. + Prior experience with solid tumor basket/umbrella trials, tumor-agnostic strategies, and adaptive development pathways. + Familiarity with indirect comparisons, external controls, and payer analytics for oncology submissions. + Contributions to ASCO, ESMO, or other oncology-related publications or working groups. + Scientific contributions through publications, presentations, or participation in industry/regulatory working groups. + Experience working with real-world data sources, including data integration, study design, and interpretation. + Strong leadership presence and ability to represent the organization in regulatory, HTA, and scientific discussions externally. **Salary Range:** $170,450 - $267,850 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 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 + Company fleet vehicle 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

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