Statistical Science Lead, Solid Tumor/Hematology (Director Biostatistics)

Astellas Pharma-posted 2 months ago

Remote • Northbrook, IL

5,001-10,000 employees

Chemical Manufacturing

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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.

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., 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.
Lead and coordinate statistical and analytics contributions from a broad QSEG team, including clinical trial biostatisticians, exploratory oncology statisticians, medical affairs statisticians, statistical programmers, biomarker/statistical genetics experts in oncology, RWE analysts/statistical epidemiologists, safety/PV statisticians, and advanced analytics and modeling specialists.
Ensure scientific alignment, quality, and integration across all statistical contributions at the compound level.
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.
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.
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.
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.

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Statistical Science Lead, Solid Tumor/Hematology (Director Biostatistics)

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