Principal Biostatistician Medical Affairs Ireland, Poland, Greece, Hungary, Romania, Ukra

Principal Biostatistician Medical Affairs ( UK, Ireland, Poland, Greece, Hungary, Romania, Ukraine, South Africa, Belgium, Netherlands)

Updated: Today
Location: London, LND, United Kingdom
Job :

• Provide statistical support to Medical Affairs group focused on exploratory analysis, observational studies, real‑world evidence, and publication support.
• Support all assigned statistical tasks during the lifecycle of the project, from protocol to Clinical Study Report (CSR).
• Prepare Statistical Analysis Plans (SAPs), including development of mock‑up displays for tables, listings, and figures, and collaborate with sponsors as required.
• Possibly lead the statistical aspects of the protocol, generate randomization schedules, publications, and input into the CSR.
• Coordinate the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely, high‑quality work.
• Provide independent review of project work produced by other biostatisticians in the department.
• Create or review programming specifications for analysis datasets, tables, listings, and figures.
• Review SAS‑annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met.
• Conduct and participate in verification and quality control of project deliverables, ensuring consistency with the SAP.
• Implement company objectives and devise alternative solutions to address business and operational challenges.
• Serve as biostatistics representative on project teams, interfacing with other departmental team members.
• Manage scheduling and time constraints across multiple projects, setting priorities and communicating challenges to management.
• Monitor progress against agreed milestones and ensure study timelines for deliverables are met; identify out‑of‑scope tasks and raise them to management.
• Provide statistical programming support as needed.
• Possibly participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and acting as an independent non‑voting biostatistician.
• Possibly lead projects involving integrated analyses, attend regulatory agency meetings, or respond to questions to support the statistical analysis results of clinical trials.
• Follow applicable SOPs, work instructions, and regulatory guidelines (e.g., ICH).
• Maintain well‑organized, complete, and up‑to‑date project documentation and verification/quality control documents, ensuring inspection readiness.
• Display willingness to work with others and assist with projects and initiatives as necessary.
• Support business development activities by contributing to proposals, budgets, and sponsor bid defense meetings.
• Coach and mentor other biostatistics staff.
• Perform other work‑related duties as assigned.

Minimal travel may be required.

Tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company may assign other tasks, duties, or responsibilities at its discretion. Equivalent experience, skills, and/or education will also be considered. The Company will determine what constitutes equivalent to the qualifications described above. Nothing contained herein should be construed to create an employment contract. The Company complies with obligations imposed by the legislation of each country in which it operates, including the EU Equality Directive and the Americans with Disabilities Act, providing reasonable accommodations as appropriate.

Medical Affairs Biostatistician – responsible for providing statistical support across the lifecycle of clinical projects in Medical Affairs.