This position is offered on behalf of a partner company that handles all applications and next steps. Our partner is seeking a Principal Statistician – Early Phase based in the Netherlands. You will be part of an international clinical research environment dedicated to advancing drug development and delivering innovative therapies to patients worldwide. In this role, you will provide strategic statistical leadership across early-phase clinical trials, supporting studies from protocol development through statistical analysis and clinical study reporting.

• Lead statistical activities across early-phase clinical trials, supporting the full study lifecycle from protocol development and study design through analysis and Clinical Study Report (CSR) preparation.
• Develop, review, and oversee Statistical Analysis Plans (SAPs), including clearly defined analytical methodologies and well-structured mock-up tables, listings, and figures.
• Serve as Lead Biostatistician on assigned projects, providing statistical input into clinical protocols, randomization schedules, study analyses, and clinical development decisions.
• Provide statistical expertise to support clinical development strategies, ensuring that study designs and analytical approaches align with scientific objectives and regulatory expectations.
• Create and review statistical programming specifications for analysis datasets, tables, listings, and figures, ensuring consistency between planned analyses and final outputs.
• Review annotated case report forms (CRFs), database designs, and other study documentation to confirm that protocol requirements are appropriately captured and support reliable statistical analyses.
• Conduct and oversee quality control and verification activities for statistical deliverables, ensuring accuracy, consistency, completeness, and compliance with approved specifications and SAPs.
• Lead complex or multiple projects, including integrated analyses and regulatory submissions, coordinating statistical activities and ensuring deliverables meet agreed timelines and quality standards.
• Collaborate with sponsors and cross-functional project teams, representing biostatistics in project discussions and communicating statistical concepts, findings, and recommendations effectively.
• Support regulatory interactions by preparing responses to agency questions, participating in regulatory meetings, and explaining statistical methods and clinical trial results when required.
• Contribute to Data Safety Monitoring Board (DSMB) and Data Monitoring Committee (DMC) activities, including charter development and participation as an independent non-voting or voting statistician, as appropriate.
• Mentor and support biostatisticians through technical guidance, independent review of their work, training sessions, and the development of training materials.
• Manage competing priorities across multiple studies, monitor progress against milestones, communicate potential delays, and escalate out-of-scope activities or resource constraints.
• Provide statistical programming support when needed and maintain complete, accurate, and inspection-ready project documentation, including quality control records and programs.
• Apply relevant standard operating procedures, work instructions, and regulatory guidelines, including International Council for Harmonisation (ICH) guidance.
• Support business development activities by contributing statistical expertise to proposals, project budgets, and sponsor bid defense meetings.
• Identify opportunities to improve statistical processes, address operational challenges, and contribute to broader departmental and organizational objectives.