Principal Statistician - Early Phase

Accountabilities:

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.
Requirements:
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.
Experience with regulatory submissions and interactions with regulatory agencies is preferred.
Strong understanding of quality assurance, verification processes, documentation standards, and applicable regulatory guidelines, including ICH.
Excellent written and verbal communication skills, with the ability to explain complex statistical concepts clearly to technical and non-technical stakeholders.
Proven ability to collaborate effectively with sponsors, programmers, clinical teams, and other cross-functional stakeholders in an international environment.
Strong organizational and project management skills, including the ability to coordinate multiple studies, manage competing deadlines, and proactively communicate risks.
Demonstrated mentoring and coaching abilities, with a commitment to developing the technical expertise of other biostatistics professionals.
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 professional clinical research setting.
Willingness to undertake occasional travel as required by project or business needs.
Availability to work remotely from an eligible European location, subject to the applicable employment and location requirements.
Benefits:
Fully remote working arrangement, with opportunities to work from eligible locations across Europe.
Full-time position offering the opportunity to contribute to meaningful clinical research and drug development programs.
Opportunity to work on sponsor-dedicated projects and collaborate with experienced professionals across biostatistics, clinical operations, programming, and regulatory functions.
Exposure to early-phase clinical trials, complex statistical challenges, and potentially regulatory submissions.
Professional development and career progression opportunities within an international life sciences environment.
Technical and therapeutic-area training to support continuous learning and specialist expertise.
Supportive management, peer recognition, and opportunities to collaborate with experienced statistical and clinical research professionals.
Opportunities to mentor colleagues, influence statistical practices, and contribute to the development of departmental capabilities.
Access to cross-functional expertise, emerging technologies, scientific knowledge, and collaborative problem-solving resources.
Inclusive working culture that encourages diverse perspectives, professional growth, and meaningful contributions.
Opportunity to help advance the development of innovative therapies and improve patient outcomes worldwide.
Potential for occasional travel to support project meetings, sponsor interactions, or other business activities.