Astellas Pharma · 2 days ago
Director Biostatistics Oncology (Statistical Science Lead)
Northbrook, IL
Full-time
Hybrid
Director/Executive
$170K/yr - $268K/yr
10+ years expAstellas Pharma is a global pharmaceutical company focused on developing innovative therapies for patients. The Director of Biostatistics Oncology will lead the statistical and analytical strategy for solid tumor oncology, overseeing a cross-functional team and ensuring scientific excellence across various studies and regulatory engagements.
BiotechnologyHealth CareMedical
Responsibilities
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
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
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
Qualification
Required
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
Broad expertise 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
Ability to lead and influence cross-functional, global teams within a matrix environment
Strong communication, collaboration, and stakeholder engagement skills across both technical and non-technical audiences
Proficiency in statistical software (e.g., SAS, R) and familiarity with simulation tools and modern statistical methods
Preferred
Prior experience in oncology or other complex therapeutic areas with evolving clinical and regulatory landscapes
Familiarity with Bayesian methods, adaptive designs, external control arms, and AI/ML applications in clinical development
Prior experience with solid tumor basket/umbrella trials, tumor-agnostic strategies, and adaptive development pathways
Familiarity with indirect comparisons, external controls, and payer analytics for oncology submissions
Contributions to ASCO, ESMO, or other oncology-related publications or working groups
Scientific contributions through publications, presentations, or participation in industry/regulatory working groups
Experience working with real-world data sources, including data integration, study design, and interpretation
Strong leadership presence and ability to represent the organization in regulatory, HTA, and scientific discussions externally
Benefits
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
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
Company
Astellas Pharma
Astellas Pharma is a global pharmaceutical research & development company.
10001+ employees
H1B Sponsorship
Astellas Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (4)
2022 (2)
2021 (3)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
National Institute on Drug Abuse (NIDA)
2020-07-22Grant
2008-10-13IPO
Leadership Team
Amanda Hart
Head, Global Commercial Analytics and Reporting
Recent News
2026-01-07
2025-12-18
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