Principal Statistician
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Job Description
Principal Biostatistician leading clinical trial design, analysis, and reporting for global CRO Worldwide Clinical Trials. Providing statistical leadership, sponsor consultation, and mentorship across regulated research studies.
Responsibilities:
- Lead statistical strategy, design, analysis, and reporting activities across one or more clinical research projects or sponsor programmes
- Develop and review Statistical Analysis Plans, study protocols, randomisation methodologies, and other key statistical deliverables
- Provide expert statistical consultation to sponsors, project teams, and external stakeholders throughout the clinical trial lifecycle
- Oversee the development, validation, and review of SAS programs, derived datasets, SDTM/ADaM datasets, and statistical outputs
- Deliver high-quality tables, figures, listings, reports, and ad hoc analyses to support study objectives and decision-making
- Collaborate with cross-functional teams, sponsors, vendors, and regulatory stakeholders to address statistical and reporting requirements
- Mentor and guide biostatisticians on study design, analytical approaches, and statistical methodology
- Contribute to process improvements, quality initiatives, policy development, and inspection-readiness activities to enhance efficiency and data quality
- Represent the biostatistics function in sponsor meetings, external forums, and scientific discussions, keeping abreast of evolving statistical and regulatory developments
Requirements:
- BSc with at least 8 years' relevant experience, MSc with at least 6 years' relevant experience, or PhD with at least 4 years' relevant experience in biostatistics or a related field
- Demonstrated experience as a lead or project biostatistician, providing statistical leadership across clinical research studies
- Broad experience applying statistical methods across multiple phases of clinical development and across a variety of therapeutic areas
- Strong knowledge of clinical trial design, statistical analysis, regulatory standards, and interactions within regulated research environments
- Advanced SAS programming expertise, including experience with SDTM, ADaM, derived datasets, and statistical reporting outputs
- Excellent project planning, prioritisation, and time-management skills, with the ability to manage multiple studies simultaneously
- Strong communication, consulting, influencing, and relationship-building skills, with experience collaborating across multidisciplinary teams and external stakeholders
- Proficiency in English, with strong written and verbal communication skills
Benefits:
- Collaborative and inclusive environment
- Growth and career development opportunities
- Opportunity to learn and grow
- Mentoring and professional development opportunities
- Opportunity to contribute to statistical methodologies and best practices
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