Astellas Pharma
Statistical Science Lead, Solid Tumor/Hematology (Director Biostatistics)
Astellas Pharma, Northbrook, Illinois, us, 60065
Overview
Statistical Science Lead, Solid Tumor/Hematology (Director Biostatistics) 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. This role is part of the Global Statistical Lead (GSTATL) within the Quantitative Science & Evidence Generation (QSEG) organization, accountable for driving the statistical and analytical strategy for a solid tumor compound or indication across its full development lifecycle. The GSTATL leads a cross-functional, integrated quantitative team supporting evidence generation and decision-making, 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 contributes to regulatory and payer strategy, internal governance, and portfolio planning for solid tumor assets. Responsibilities And Accountabilities
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., 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. 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, and advanced analytics and modeling specialists. Ensure scientific alignment, quality, and integration across all statistical contributions at the compound level. Regulatory and HTA Engagement
Represent Astellas on 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 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. Mentorship and Capability Development
Mentor statisticians and analytics professionals across QSEG, supporting 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. 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. Qualifications
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 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. Salary Range
$175K – $240K (NOTE: Final salary could be more or less, based on experience) Benefits
Medical, Dental and Vision Insurance Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks 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 Referral bonus program EOE including Disability/Protected Veterans Category
Quantitative Sciences & Evidence Generation Astellas is committed to equality of opportunity in all aspects of employment. "
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Statistical Science Lead, Solid Tumor/Hematology (Director Biostatistics) 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. This role is part of the Global Statistical Lead (GSTATL) within the Quantitative Science & Evidence Generation (QSEG) organization, accountable for driving the statistical and analytical strategy for a solid tumor compound or indication across its full development lifecycle. The GSTATL leads a cross-functional, integrated quantitative team supporting evidence generation and decision-making, 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 contributes to regulatory and payer strategy, internal governance, and portfolio planning for solid tumor assets. Responsibilities And Accountabilities
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., 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. 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, and advanced analytics and modeling specialists. Ensure scientific alignment, quality, and integration across all statistical contributions at the compound level. Regulatory and HTA Engagement
Represent Astellas on 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 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. Mentorship and Capability Development
Mentor statisticians and analytics professionals across QSEG, supporting 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. 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. Qualifications
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 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. Salary Range
$175K – $240K (NOTE: Final salary could be more or less, based on experience) Benefits
Medical, Dental and Vision Insurance Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks 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 Referral bonus program EOE including Disability/Protected Veterans Category
Quantitative Sciences & Evidence Generation Astellas is committed to equality of opportunity in all aspects of employment. "
#J-18808-Ljbffr