Statistical Science Lead, Biomarker (Director)

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop 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 Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity 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 Statistical Science Lead in the Early and Exploratory Statistical Science group plays a pivotal role and provides statistical leadership in the development and validation of biomarkers across preclinical through clinical development for multiple compounds.  They provide strategic and technical leadership in designing studies, analyzing data, and interpreting results to support biomarker hypothesis. This includes ensuring statistical rigor in exploratory and confirmatory analyses, collaborating closely with translational scientists, precision medicine scientists, and clinicians, and guiding the integration of multi-dimensional biomarker data into clinical development plans.  Their work helps bridge early research with clinical application, enabling data driven decision for patient stratification, efficacy assessment and safety monitoring.

Essential Job Responsibilities:

Provides best in class Quantitative Sciences and Evidence Generation (QSEG) support to Astellas drug development programs and for studies with assigned projects, provides all required statistical biomarker support and deliverables by supervising another biomarker statistician, or as a member of a project team.

• Lead multiple complex projects across preclinical and clinical development phases, providing strategic direction and execution of statistical activities in support of Translational Science, Precision Medicine, and additional Biomarker plans.
• Collaborate with cross-functional project teams to develop biomarker strategies by integrating and analyzing data from diverse sources (i.e. preclinical data, clinical data, RWD, and publications)
• Develop and/or implement advanced statistical methodologies and innovative machine learning algorithms to transform complex biomarker data into actionable insights that inform and accelerate drug development
• Develop biomarker section in clinical trial protocols and biomarker analysis plans
• Contribute statistical expertise in the development of companion diagnostics by designing and analyzing studies that identify and validate predictive biomarkers for patient stratification and treatment response
• Collaborate with cross-functional teams in developing strategy for analyzing and assessing biomarker imaging data and molecular biomarker data, including genomics and proteomics, to support decision making and drug development.
• Lead statistical strategy and representation for biomarker-related topics for regulatory responses and meetings.

Mentorship and Capability Development:

• Mentor statisticians and analytics professionals, 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.
• Lead or contribute to internal initiatives, including standardization efforts, methodology forums, and innovation networks.

Qualifications:

Required

• PhD (or MS with equivalent experience) in Biostatistics, Statistics, or a related quantitative
• Minimum of 9 years (12+ years for MS) of experience in pharmaceutical or related industry in preclinical to clinical development with proven leadership in statistical and AI/ML strategy.
• Strong understanding of the drug development lifecycle, regulatory requirements, and evidence
• generation
• 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.
• Advance and broad knowledge of classical and modern statistical methodology, AI/ML algorithms, and simulation tools, along with understanding of industry best practices related to analysis of clinical and biomarker data.
• Knowledge and proficiency in implementing statistical software (e.g., SAS, R, Python)

Preferred:

• Experience integrating and analyzing real world data sources to identify biomarkers for disease progression, treatment response, and patient stratification
• Broad expertise across clinical trial statistics, exploratory statistics, Medical Affairs statistics, safety/PV statistics, real-world evidence (RWE) analytics, and statistical programming
• Scientific contributions through publications, presentations, or participation in industry/regulatory working groups 

Salary Range:

$170,450 – $267,850  (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

#LI-SS