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About Astellas
Astellas is a progressive health partner, delivering value and outcomes where needed.

Description
Statistical Science Lead, Director

Astellas is a progressive health partner, delivering value and outcomes where needed.

The company pursues innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

Astellas works directly with patients, doctors, and health care professionals on the front line to ensure patient and clinical needs are guiding development activities at every stage.

The Opportunity
Join an organisation at the forefront of healthcare innovation, transforming cutting-edge science into value for patients.

As a Global Statistical Lead for Haematology Oncology, you will be a compound-level leader within the Quantitative Science & Evidence Generation organisation, accountable for driving the statistical and analytical strategy for a compound or indication across its full development lifecycle.

Key Responsibilities

• Ensuring consistency and scientific excellence across studies, indications, and evidence type, while enabling innovation in statistical methodology, clinical development optimisation, and external engagement.
• Providing strategic statistical leadership - Serving as the compound-level statistical lead for haematology oncology, responsible for end-to-end quantitative strategy supporting clinical development, evidence generation, and regulatory/payer interactions.
• Leading the development of integrated statistical strategies across all relevant study types and functions.
• Ensuring Cross-Functional Team Leadership: Leading a diverse team of statisticians and analysts across clinical, medical affairs, RWE, safety, and biomarker domains to ensure scientific integration and quality.
• Representing Astellas in global regulatory and payer interactions, guiding statistical content for submissions and evidence strategies.

Essential Knowledge & Experience

• Demonstrable experience in oncology clinical development, with proven leadership in statistical strategy and regulatory submissions.
• Proven 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.
• Worked 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.

Preferred Experience & Qualifications

• PhD (or MSc with equivalent experience) in Biostatistics or Statistics.
• Prior experience with oncology basket/umbrella trials, tumour-agnostic strategies, and adaptive development pathways.
• Familiarity with indirect comparisons, external controls, and payer analytics for oncology submissions.
• Scientific contributions through publications, presentations, or participation in industry/regulatory working groups.
• Strong leadership presence and ability to represent the organization in regulatory, HTA, and scientific discussions externally.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.