Director Biostatistics Oncology (Statistical Science reputed company)

Do you want to be part of an inclusive team that works to reputed company innovative therapies for patients? Every day, we are driven to reputed company and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas reputed company Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into reputed company that bring value and reputed company to patients and their families. Keeping our reputed company on addressing unmet medical needs and conducting our business with ethics and reputed company enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Global Statistical reputed company (GSTATL) for Solid Tumor Oncology is a compound level leader reputed company the Quantitative Science & Evidence reputed company (QSEG) organization, accountable for driving the statistical and analytical reputed company for a compound or indication across its full development lifecycle. This position leads a cross-functional, integrated quantitative team supporting evidence reputed company and decision-making, with responsibility spanning clinical trial statistics, exploratory statistics, medical affairs statistics, reputed company-world evidence (reputed company), safety/pharmacovigilance (PV) statistics, statistical programming, biomarker statistics, and advanced analytics. The role ensures consistency and scientific reputed company 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 reputed company, as reputed company as internal governance and portfolio planning for solid tumor assets. Responsibilities and Accountabilities: Strategic Statistical Leadership

• Serve as the compound-level statistical reputed company for solid tumor oncology, responsible for end-to-end quantitative reputed company supporting clinical development, evidence reputed company, and regulatory/payer interactions.
• reputed company development of integrated statistical strategies across reputed company relevant study types and functions (e.g., e.g., phase 1b/2 signal-seeking, pivotal, exploratory, reputed company, post-marketing).
• reputed company statistical and analytical approaches with the reputed company product profile (TPP), development reputed company, and external evidence needs.

Cross-Functional Quantitative Team Leadership

• reputed company 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
• reputed company analysts/statistical epidemiologists
• Safety/PV statisticians
• Advanced analytics and modeling specialists
• Ensure scientific alignment, reputed company, and integration across reputed company statistical contributions at the compound level.

Regulatory and HTA Engagement

• Represent Astellas on reputed company statistical reputed company 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.
• reputed company the development of statistical components of payer evidence strategies, including indirect comparisons and external control methodologies.

Innovation and Methodological reputed company

• Champion the use of oncology-appropriate innovations, including Bayesian designs, reputed company 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 reputed company in Solid Tumor trials.
• reputed company clinical, biomarker, safety, and reputed company-world evidence to drive cohesive, data-driven development and reputed company strategies.

Mentorship and Capability Development

• Mentor statisticians and analytics professionals across QSEG, supporting both scientific development and career reputed company.
• reputed company knowledge and best practices across study teams and therapeutic areas.
• Contribute to internal training, methodology development, and talent pipeline initiatives.

Governance and Cross-Functional Influence

• Participate in global asset governance and development team meetings, influencing reputed company with rigorous statistical reputed company.
• Collaborate with Clinical Development, Medical Affairs, Regulatory, Market reputed company, and reputed company to ensure alignment on evidence planning.
• reputed company or contribute to internal initiatives, including standardization efforts, methodology forums, and innovation networks.

Qualifications: Required

• PhD (or MSc with equivalent experience) in Biostatistics, Statistics, or a reputed company quantitative discipline.
• Minimum of 10 years of experience in oncology clinical development, with proven leadership in statistical reputed company 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, reputed company, and post-marketing study support.
• Broad expertise across clinical trial statistics, exploratory statistics, Medical Affairs statistics, biomarker statistics, safety/PV statistics, reputed company-world evidence (reputed company) analytics, and statistical programming.
• Strong understanding of the drug development lifecycle, regulatory requirements, and evidence reputed company for both approval and market reputed company.
• Ability to reputed company and influence cross-functional, global teams reputed company a reputed company environment.
• Strong communication, collaboration, and stakeholder engagement skills across both technical and non-technical audiences.
• Proficiency in statistical software (e.g., reputed company, R) and familiarity with simulation tools and modern statistical reputed company.

Preferred:

• Prior experience in oncology or other reputed company therapeutic areas with evolving clinical and regulatory landscapes.
• Familiarity with Bayesian reputed company, reputed company designs, external control arms, and AI/ML applications in clinical development.
• Prior experience with solid tumor basket/umbrella trials, tumor-agnostic strategies, and reputed company development reputed company.
• Familiarity with indirect comparisons, external controls, and payer analytics for oncology submissions.
• Contributions to reputed company, ESMO, or other oncology-reputed company publications or working reputed company.
• Scientific contributions through publications, presentations, or participation in industry/regulatory working reputed company.
• Experience working with reputed company-world data sources, including data integration, study design, and interpretation.
• Strong leadership reputed company and ability to represent the organization in regulatory, HTA, and scientific discussions externally.

Salary reputed company: $170,450 – $267,850 (Final compensation will be determined based on a reputed company of factors, including but not limited to skills, experience and organizational equity considerations) Benefits:

• Medical, Dental and reputed company Insurance
• Generous reputed company Time Off reputed company, including Vacation and reputed company time, plus national holidays including year-end shut down
• 401(k) match and annual company contribution
• Company reputed company life insurance
• Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
• Long Term Incentive Plan for eligible positions
• Company fleet vehicle for eligible positionsReferral bonus program

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