Statistical Science Lead, Director

Astellas Pharma

  • United Kingdom
  • Permanent
  • Full-time
  • 1 month ago
Statistical Science Lead, DirectorAbout Astellas:At Astellas we are making treatments that matter to people.We are tackling the toughest health challenges putting the patient at the heart of every move we make.Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients' lives.From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.The Opportunity:Would you like to join an organisation at the forefront of healthcare innovation, transforming cutting-edge science into VALUE for patients? Bring your unique skills, experience, perspectives, and ideas to Astellas.As a Global Statistical Lead, (GSTATL) for Haematology Oncology you will be a compound level leader within the Quantitative Science & Evidence Generation (QSEG) organisation, accountable for driving the statistical and analytical strategy for a compound or indication across its full development lifecycle.You will lead 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 reports to the Head, Statistical Science, Oncology / Immuno-Oncology and is located in Bourne, UK.Hybrid Working:At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.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. The GSTATL plays a key role in regulatory and payer strategy, as well as internal governance and portfolio planning for haematology oncology assets.
  • 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 (e.g., e.g., phase 1b/2 signal-seeking, pivotal, exploratory, RWE, post-marketing). Aligning statistical and analytical approaches with the target product profile (TPP), development strategy, and external evidence needs.
  • 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. Leading on all statistical matters in global regulatory interactions (e.g., FDA, EMA, PMDA). Guiding preparation of statistical content for regulatory submissions, briefing packages, and health technology assessment (HTA) dossiers.
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 & Qualification:
  • 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.
  • Familiarity with Bayesian methods, adaptive designs, external control arms, and AI/ML applications in clinical development. Experience working with real-world data sources, including data integration, study design, and interpretation.
  • Scientific contributions through publications, presentations, or participation in industry/regulatory working groups. Contributions to ASCO, ESMO, or other oncology-related publications or working groups.
  • Strong leadership presence and ability to represent the organization in regulatory, HTA, and scientific discussions externally.
Education:
  • Educated to M.S level or higher (or equivalent) in Biostatistics, Statistics.
Additional information:
  • The is a permanent full-time position.
  • This position is based in the UK.
  • This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
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.#LI-Bourne
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Astellas Pharma