Principal Biostatistician Medical Affairs ( UK, Ireland, Poland, Greece, Hungary, Romania, Ukra[...]

Principal Biostatistician – Medical Affairs

Locations: UK, Ireland, Poland, Greece, Hungary, Romania, Ukraine, South Africa, Belgium, Netherlands

Job Overview

Provide statistical support to the Medical Affairs group, focusing on exploratory analysis, observation studies, real‑world evidence, and publication support throughout the project lifecycle.

Responsibilities

• Support all statistical tasks from protocol development to clinical study report.
• Prepare Statistical Analysis Plans (SAPs) and well‑presented mock‑up displays for tables, listings, and figures.
• Contribute to protocol statistical aspects, randomisation schedules, publications, and inputs to the CSR.
• Coordinate and review work of biostatisticians and statistical programmers to ensure timely, high‑quality outputs.
• Develop or review programming specifications and assess CRFs, database design, and other study documentation for protocol compliance.
• Participate in verification, quality control, and ensure deliverables meet expectations.
• Create alternative solutions for business and operational challenges.
• Represent the biostatistics team on project meetings, interfacing with other departments.
• Manage scheduling, priorities, and communicate timeline changes to management.
• Monitor study activities against milestones, raise out‑of‑scope tasks to management.
• Provide statistical programming support as needed.
• Participate in data safety monitoring activities, serve as an independent non‑voting biostatistician when required.
• Lead integrated analyses, attend regulatory meetings or respond to queries on behalf of the sponsor.
• Adhere to SOPs, WIs, and regulatory guidelines (e.g., ICH).
• Maintain comprehensive project documentation and quality control documents for inspection readiness.
• Support business development through proposals, budgets, and sponsor bid defense meetings.
• Coach and mentor other biostatistics staff.
• Perform additional duties as assigned and support business initiatives.
• Travel may be required (minimal).

Qualifications

• Must be located in one of the specified regions (UK, Ireland, Poland, Greece, Hungary, Romania, Ukraine, South Africa, Belgium, Netherlands).
• Previous clinical experience within Clinical Trials.
• Proficiency in English to submit CVs and work with international teams.

Additional Information

Tasks, duties, and responsibilities as listed are not exhaustive. The Company may assign other tasks at its discretion. Equivalent experience, skills, or education will also be considered. The Company is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations when appropriate.