Principal Biostatistician Medical Affairs (Europe Only)

Principal Biostatistician, Medical Affairs (Europe Only)

Responsibilities

• Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
• Prepares Statistical Analysis Plans (SAPs), including development of well‑presented mock‑up displays for tables, listings, and figures. Collaborates with the sponsor, if required.
• May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
• Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department.
• Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
• Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
• Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
• Implements company objectives, and creates alternative solutions to address business and operational challenges.
• Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives.

  Includes preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.

• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by re‑organizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
• Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out-of-scope tasks and escalates to management.
• Provides 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, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up‑to‑date project documentation, verification/quality control documents, and programs; ensuring inspection readiness.
• Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
• Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Coaches and mentors other Biostatistics staff.
• Performs other work‑related duties as assigned.
• Minimal travel may be required.

Qualifications

• Must be located in UK, Ireland, Poland, Spain, Greece, Hungary, Romania, Ukraine, Belgium, Netherlands, France.
• Previous Medical Affairs experience within Clinical Trials required.

Additional Information

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 as equivalent to the qualifications described above.

Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.