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 practices across study teams and therapeutic areas.
• Contribute to internal training, methodology development, and talent pipeline initiatives.

1. Governance and Cross-Functional Influence

• 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.

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.
• A 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.
• 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.

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 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 optimize 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.

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 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

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