Principal Statistician - Early Phase

<h3>Accountabilities:</h3><li>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.</li><li>Develop, review, and oversee Statistical Analysis Plans (SAPs), including clearly defined analytical methodologies and well-structured mock-up tables, listings, and figures.</li><li>Serve as Lead Biostatistician on assigned projects, providing statistical input into clinical protocols, randomization schedules, study analyses, and clinical development decisions.</li><li>Provide statistical expertise to support clinical development strategies, ensuring that study designs and analytical approaches align with scientific objectives and regulatory expectations.</li><li>Create and review statistical programming specifications for analysis datasets, tables, listings, and figures, ensuring consistency between planned analyses and final outputs.</li><li>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.</li><li>Conduct and oversee quality control and verification activities for statistical deliverables, ensuring accuracy, consistency, completeness, and compliance with approved specifications and SAPs.</li><li>Lead complex or multiple projects, including integrated analyses and regulatory submissions, coordinating statistical activities and ensuring deliverables meet agreed timelines and quality standards.</li><li>Collaborate with sponsors and cross-functional project teams, representing biostatistics in project discussions and communicating statistical concepts, findings, and recommendations effectively.</li><li>Support regulatory interactions by preparing responses to agency questions, participating in regulatory meetings, and explaining statistical methods and clinical trial results when required.</li><li>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.</li><li>Mentor and support biostatisticians through technical guidance, independent review of their work, training sessions, and the development of training materials.</li><li>Manage competing priorities across multiple studies, monitor progress against milestones, communicate potential delays, and escalate out-of-scope activities or resource constraints.</li><li>Provide statistical programming support when needed and maintain complete, accurate, and inspection-ready project documentation, including quality control records and programs.</li><li>Apply relevant standard operating procedures, work instructions, and regulatory guidelines, including International Council for Harmonisation (ICH) guidance.</li><li>Support business development activities by contributing statistical expertise to proposals, project budgets, and sponsor bid defense meetings.</li><li>Identify opportunities to improve statistical processes, address operational challenges, and contribute to broader departmental and organizational objectives.</li><h2>Requirements:</h2><li>Graduate degree in Biostatistics or a closely related quantitative discipline, such as Statistics, Mathematics, or a relevant scientific field.</li><li>Extensive experience in clinical trials and biostatistics, with a demonstrated ability to lead multiple projects or programs of studies independently.</li><li>Proven program- or project-level leadership experience, including meaningful contributions to clinical development strategy and statistical decision-making.</li><li>Strong proficiency in R programming, with the ability to apply statistical programming techniques to clinical research and analysis requirements.</li><li>Comprehensive knowledge of statistical study design, analytical methodologies, clinical trial data interpretation, and relevant regulatory requirements.</li><li>Experience supporting the full statistical lifecycle of clinical trials, from protocol development and SAP preparation through analysis, quality control, and CSR delivery.</li><li>Demonstrated ability to develop and review statistical analysis plans, programming specifications, and statistical outputs, including tables, listings, and figures.</li><li>Experience with regulatory submissions and interactions with regulatory agencies is preferred.</li><li>Strong understanding of quality assurance, verification processes, documentation standards, and applicable regulatory guidelines, including ICH.</li><li>Excellent written and verbal communication skills, with the ability to explain complex statistical concepts clearly to technical and non-technical stakeholders.</li><li>Proven ability to collaborate effectively with sponsors, programmers, clinical teams, and other cross-functional stakeholders in an international environment.</li><li>Strong organizational and project management skills, including the ability to coordinate multiple studies, manage competing deadlines, and proactively communicate risks.</li><li>Demonstrated mentoring and coaching abilities, with a commitment to developing the technical expertise of other biostatistics professionals.</li><li>A proactive, analytical, and solution-oriented mindset, with strong attention to detail, professional judgment, and accountability for the quality of statistical deliverables.</li><li>Fluency in English, with the ability to read, write, speak, and understand English effectively in a professional clinical research setting.</li><li>Willingness to undertake occasional travel as required by project or business needs.</li><li>Availability to work remotely from an eligible European location, subject to the applicable employment and location requirements.</li><h2>Benefits:</h2><li>Fully remote working arrangement, with opportunities to work from eligible locations across Europe.</li><li>Full-time position offering the opportunity to contribute to meaningful clinical research and drug development programs.</li><li>Opportunity to work on sponsor-dedicated projects and collaborate with experienced professionals across biostatistics, clinical operations, programming, and regulatory functions.</li><li>Exposure to early-phase clinical trials, complex statistical challenges, and potentially regulatory submissions.</li><li>Professional development and career progression opportunities within an international life sciences environment.</li><li>Technical and therapeutic-area training to support continuous learning and specialist expertise.</li><li>Supportive management, peer recognition, and opportunities to collaborate with experienced statistical and clinical research professionals.</li><li>Opportunities to mentor colleagues, influence statistical practices, and contribute to the development of departmental capabilities.</li><li>Access to cross-functional expertise, emerging technologies, scientific knowledge, and collaborative problem-solving resources.</li><li>Inclusive working culture that encourages diverse perspectives, professional growth, and meaningful contributions.</li><li>Opportunity to help advance the development of innovative therapies and improve patient outcomes worldwide.</li><li>Potential for occasional travel to support project meetings, sponsor interactions, or other business activities.</li>