Job Summary

This Senior Director, Biostatistics position serves as the Head of the Early Phase Biostatistics group supporting EDO (Early Development Oncology).  The position is accountable for the statistical strategy, scientific quality, organizational capability, and effective delivery of Biostatistics support and deliverables (e.g. SAP, protocol) across the EDO portfolio through POC (proof of concept) and transition to late-stage development.  The incumbent provides strategic statistical leadership and collaborates with EDO stakeholders on clinical development plan strategy, study design including innovative statistical methods, endpoint design and selection, dose escalation, dosage optimization, cohort expansion, proof-of-concept assessment, and program advancement decisions. A strong understanding and experience in statistical analysis for biomarkers, PK, and other critical early phase assessments is required. The position serves as the senior Biostatistics partner to EDO leadership, global project teams, and key cross-functional stakeholders, and represents Biostatistics in global regulatory and Health Authority interactions.  The incumbent is also accountable for group-level resource planning and prioritization, operational excellence, development of Early Phase Biostatistics capabilities, and the performance and development of the team.  In addition, the position actively supports the broader Global Biostatistics function through global standards, talent development, cross-regional collaboration, and strategic initiatives, and works closely with Data Management and Statistical Programming for the on time study deliverables (e.g. CSRs, DSURs, etc)

Responsibilities

Early Development Strategic Leadership and Development Decision Support

• Provides strategic Biostatistics leadership and consultancy across the EDO portfolio, including biomarkers, innovative study design, dose escalation, dose and schedule optimization, cohort expansion, proof-of-concept assessment, and program advancement or transition decisions.
• Ensures that study and development strategies are scientifically rigorous, operationally feasible, and aligned with global regulatory expectations and the intended POC decision framework.
• Partners with stakeholders across EDO, BDM and other functions as a senior organizational leader.
• Reviews, challenges, and endorses critical statistical assumptions, decision criteria, and recommendations, and communicates material uncertainties, risks, and trade-offs to EDO leadership and senior management.
• Provides statistical leadership for dose optimization strategies and quantitative benefit-risk evaluation across the Early Development portfolio.
• Leads the evaluation, adoption, and advancement of innovative and contemporary statistical and early phase drug development methodologies to enhance scientific rigor, decision-making, and operational effectiveness across the group.

Statistical and Portfolio Oversight

• Provides consultancy and oversight of statistical strategies and deliverables across Early Phase programs and studies, including protocols, statistical analysis plans, design simulations, clinical study reports, regulatory documents, and scientific communications.
• Ensures scientific quality, consistency, and timely delivery of statistical work across the portfolio.
• Serves as the senior point of escalation for complex statistical, scientific, quality, prioritization, and delivery issues and drives timely resolution with relevant stakeholders.
• Defines and evolves the Early Phase Biostatistics strategy, operating model, and capability roadmap.
• Promotes appropriate use of innovative trial designs, Bayesian and adaptive methods, modeling, simulation, and other quantitative approaches in partnership with relevant statistical and scientific cross-function experts.
• Provides strategic statistical input to global regulatory strategies, briefing packages, submissions, and responses.
• Represents Biostatistics in key Health Authority interactions and supports the communication and defense of statistical approaches.
• Partners closely with Data Management and Statistical Programming on study deliverables.

Responsibilities Continued

Portfolio Resource Planning and People Leadership

• Establishes priorities and allocates Biostatistics resources across the Early Phase portfolio.
  Recruits, develops, retains, and deploys talent to meet current and future portfolio needs. Coaches and develops statisticians that strengthen technical, strategic, and leadership capabilities.
• Sets clear expectations for scientific quality, accountability, collaboration, communication, and stakeholder leadership.

Global Biostatistics Function Leadership and Support

• Contributes to the vision, strategy, priorities, and operating model of the Global Biostatistics function and represents Early Phase needs and perspectives in functional leadership discussions.
• Participates as a core member of the Biostatistics Leadership Team.

Qualifications

Education Qualifications

• PhD  in statistics or Biostatistics required

Experience Qualifications

• 10 or more years relevant experience in the pharmaceutical industry
• 4 or more years supervisory experience
• 4 or more years Early Phase Clinical Development  experience

Competencies

• Demonstrated experience leading Early Phase oncology statistical strategy, including dose-finding, dose optimization, and proof-of-concept studies, required.
• Expertise and experience in statistical methodologies for Early Phase Development, such as Bayesian methods, adaptive designs, dose-finding approaches, modeling and simulation, statistical decision-making frameworks.
• Experience working on global project and BDM teams across different time zones, including partnering with Biostatisticians across Japan, China, EU and US.
• Experience attending regulatory meetings, supporting briefing documents and responding to regulatory questions including IND and EOP2 milestones.
• Strong written and verbal communication skills
• Proficiency in SAS and/or R required.
• Strong understanding and practical experience in statistical analyses and interpretation of biomarker, PK/PD, immunogenicity, and other quantitative endpoints commonly used in Early Phase oncology development.
• Demonstrated ability to provide real-time statistical consultation and recommendations in fast-paced, cross-functional discussions. 
• Demonstrated ability to evaluate and discuss multiple statistical design options and support the selection of fit-for-purpose development strategies

Travel Requirements
Ability to travel up to 10% of the time. Travel required 10%