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

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

Updated: Yesterday
Location: Amsterdam, NH, Netherlands
Job : -OTHLOC-3528-2DR

• Provide statistical support to the Medical Affairs group focused on exploratory analysis, observation 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 the development of well‑presented mock‑up displays for tables, listings, and figures. Collaborate with the sponsor, if required.
• May be responsible for the statistical aspects of the protocol, generation of randomization schedules, publications, and input to the clinical study report.
• Coordinate the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of 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 and all data are captured as required.
• Conduct and participate in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in the SAP and specifications.
• Implement company objectives and create alternative solutions to address business and operational challenges.
• Serve as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
• Manage scheduling and time constraints across multiple projects, set goals based on management priorities, adapt to timeline or priority changes, and proactively communicate to biostatistics management any difficulties with meeting these timelines.
• Monitor progress on study activities against agreed milestones and ensure study timelines for project deliverables are met. Identify out‑of‑scope tasks and escale to management.
• Provide statistical programming support as needed.
• May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non‑voting biostatistician.
• May lead projects involving integrated analyses, attend regulatory agency meetings, or respond to questions to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).
• Maintain well‑organized, complete, and up‑to‑date project documentation, and verification/quality control documents and programs, ensuring inspection readiness.
• Display willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Coach and mentor other Biostatistics staff.
• Perform other work‑related duties as assigned.
• Minimal travel may be required.

• Must be located in UK, Ireland, Poland, Greece, Hungary, Romania, Ukraine, South Africa, Belgium, or Netherlands.
• Previous clinical experience within Clinical Trials is required.
• Strong knowledge of statistical methods and real‑world evidence.
• Excellent communication skills and ability to collaborate with multidisciplinary teams.

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes…