Join an international clinical research environment dedicated to advancing drug development and bringing innovative therapies to patients worldwide. As a Principal Statistician, you will provide strategic statistical leadership across early-phase clinical trials, supporting studies from protocol development through statistical analysis and clinical study reporting. You will collaborate with sponsors, clinical teams, programmers, and regulatory stakeholders to ensure robust study designs, reliable data interpretation, and high-quality deliverables. In this senior role, you will oversee complex projects, mentor biostatistics colleagues, and contribute to clinical development strategies and regulatory submissions. You will also help strengthen statistical methodologies, quality standards, and operational efficiency across multiple studies. This fully remote opportunity offers the flexibility to work from eligible locations across Europe while contributing to impactful research within a collaborative, science-driven environment. 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. 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. 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. Provide statistical programming support when needed and maintain complete, accurate, and inspection-ready project documentation, including quality control records and programs. Support business development activities by contributing statistical expertise to proposals, project budgets,



and sponsor bid defense meetings. Graduate degree in Biostatistics or a closely related quantitative discipline, such as Statistics, Mathematics, or a relevant scientific field. Extensive experience in clinical trials and biostatistics, with a demonstrated ability to lead multiple projects or programs of studies independently. Proven program
- or project-level leadership experience, including meaningful contributions to clinical development strategy and statistical decision-making. Strong proficiency in R programming, with the ability to apply statistical programming techniques to clinical research and analysis requirements. Comprehensive knowledge of statistical study design, analytical methodologies, clinical trial data interpretation, and relevant regulatory requirements. Experience supporting the full statistical lifecycle of clinical trials, from protocol development and SAP preparation through analysis, quality control, and CSR delivery. Demonstrated ability to develop and review statistical analysis plans, programming specifications, and statistical outputs, including tables, listings, and figures. Strong understanding of quality assurance, verification processes, documentation standards, and applicable regulatory guidelines, including ICH. Strong organizational and project management skills, including the ability to coordinate multiple studies, manage competing deadlines, and proactively communicate risks. A proactive, analytical, and solution-oriented mindset, with strong attention to detail, professional judgment, and accountability for the quality of statistical deliverables. Fluency in English, with the ability to read, write, speak, and understand English effectively in a prof

📌 Senior Statistician (España)
🏢 Jobgether
📍 España