Head of Early Phase Biostatistics

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

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).

• 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.

• 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…