Director, Early Phase Biostatistics

Location: Basking Ridge

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.

Job Summary This Director, Biostatistics position provides statistical leadership and hands-on delivery for Early Phase Biostatistics supporting EDO (Early Development Oncology). The position is accountable for the statistical strategy, scientific quality, and timely delivery of Biostatistics support across multiple assigned studies and/or projects through POC (proof of concept) and transition to late-stage development. The incumbent serves as the Biostatistics representative on Global Project Teams (GPTs) and study teams and directly leads or delivers key statistical activities, including study design, protocol and clinical study report development, statistical analysis plans, analysis specifications, modeling and simulation, review of mock tables, figures, and listings (TFLs), and quality review of ADaM datasets and TFLs.

The incumbent partners with EDO stakeholders on clinical development strategy, endpoint design and selection, dose escalation, dose and schedule optimization, cohort expansion, proof-of-concept assessment, and program advancement decisions. The position provides statistical leadership and oversight across assigned studies and/or projects, supports global regulatory strategy and Health Authority interactions, and manages competing priorities in a fast-paced, dynamic environment. The incumbent applies advanced knowledge of clinical trial design and analysis, including dose-finding methodologies, adaptive and innovative trial designs, biomarker-driven development, modeling and simulation, and emerging statistical approaches relevant to early oncology drug development.

The incumbent may coach statisticians and contribute to Early Phase and Global Biostatistics standards, capabilities, and strategic initiatives. The position works closely with Data Management and Statistical Programming to ensure timely, high-quality study deliverables. Responsibilities Hands-on Statistical Leadership and Delivery Provides hands-on statistical leadership and delivery across multiple assigned Early Phase studies and/or projects and serves as the Biostatistics representative on GPTs and study teams.

Leads or directly contributes to protocol development, case report form review, statistical analysis plans and analysis specifications, statistical programming specifications, modeling and simulation, statistical analyses, results interpretation, clinical study reports, regulatory documents, and scientific communications. Develops and/or reviews mock TFLs and performs quality review of ADaM datasets, TFLs, and other statistical deliverables to ensure accuracy, consistency with the protocol and SAP, and fitness for the intended decision-making purpose.

Works closely with Data Management, Statistical Programming, CROs, and other partners to resolve implementation issues and ensure high-quality, timely delivery. Plans and manages the scope, timelines, priorities, dependencies, and resources for assigned statistical deliverables and proactively communicates and escalates material risks or gaps. Maintains accountability for delegated CRO/vendor statistical activities, including scientific quality, compliance, budget and timeline expectations.…