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. 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 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, RWE analysts, safety/PV statisticians, and advanced analytics 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) and guide the preparation of statistical content for regulatory submissions, briefing packages, and health technology assessment dossiers. Lead the development of statistical components of payer evidence strategies, including indirect comparisons and external control methodologies. Champion oncology-appropriate innovations such as Bayesian designs, adaptive trial designs, external controls, tumor-agnostic approaches, and AI/ML tools. 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 scientific development and career growth, sharing knowledge and best practices, and contributing to internal training and talent pipeline initiatives. Participate in global asset governance and development team meetings, influencing decisions with rigorous statistical insight, collaborating with Clinical Development, Medical Affairs, Regulatory, Market Access and Commercial teams, and leading or contributing to internal initiatives such as standardization efforts, methodology forums, and innovation networks. Required Qualifications Advanced degree (PhD, MD, MBA or equivalent) in Oncology, Life Sciences or a related field. Minimum 8 years of experience in pharmaceutical R&D, external innovation, academic collaboration or scientific partnering. Strong understanding of oncology drug discovery, translational science and modality platforms (e.g., next‑gen ADCs, engineered biologics, engineered small molecules). Proven ability to engage with scientific leaders and navigate early‑stage biotech and academic ecosystems. Excellent communication skills with the ability to synthesize complex scientific information into strategic insights. Prior experience in academic liaison, external innovation or strategic scouting in pharma/biotech or venture ecosystems. Familiarity with CI platforms, digital literature monitoring tools and academic/biotech databases. Strong network in academia or biotech focused on oncology. Experience in competitive intelligence, scientific scouting or innovation strategy within oncology. Familiarity with academic–industry collaboration models and consortia‑based innovation. High digital literacy and comfort with landscape analytics, scientific intelligence platforms and conference tracking tools. Preferred Qualifications 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. 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 technical and non‑technical audiences. Proficiency in statistical software (e.g., SAS, R) and familiarity with simulation tools and modern statistical methods. Location and Working Environment This position is based in Northbrook, IL. Remote work from anywhere in the US is available. At Astellas we recognize the importance of work/life balance and offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. What Awaits You at Astellas Global collaboration: become part of a connected global business of like‑minded life science leaders dedicated to improving patients’ lives worldwide. Real‑world patient impact: contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day. Relentless innovation: join a company at the forefront of scientific breakthroughs, where you have the opportunity to shape the future of healthcare. A culture of growth: chart your own course within a supportive environment that values your contributions, champions your development and empowers you to pursue your passions. Our Organizational Values and Behaviors Innovation, Integrity and Impact sit at the heart of what we do. We come together as One Astellas, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution. Salary Range $170,450 - $243,500 (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 shutdown 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 Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans. #J-18808-Ljbffr