Statistical Science Lead, Oncology Solid Tumor (Director Biostatistics)

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

 

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

 

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:

1. 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.

1. 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.

1. 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.

1. Mentorship and Capability Development

• Mentor statisticians and analytics professionals across QSEG, supporting both scientific development and career growth.
• Share knowledge and best pr