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)

Location: Dublin, CW, Ireland

Job Responsibilities

• Provide statistical support to the Medical Affairs group focused on exploratory analysis, observational studies, real world evidence, and publication support.
• Support all assigned statistical tasks throughout the project lifecycle, from protocol development to the 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 as 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 biostatisticians and statistical programmers on assigned projects to ensure timely completion of high quality work, and provide independent reviews of their outputs.
• 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 for a high quality database and planned analysis.
• Conduct and participate in verification and quality control of project deliverables, ensuring that output meets expectations and matches the analysis described in the SAP and specifications.
• Implement company objectives and create alternative solutions to address business and operational challenges.
• Serve as the biostatistics representative on project teams, inter facing as necessary with other departmental project team representatives. Prepare in advance for internal meetings, contribute ideas, and demonstrate respect for others' opinions.
• Manage scheduling and time constraints across multiple projects, set goals based on priorities from management, adapt to timeline or priority changes by reorganizing daily workload, and proactively communicate difficulties in meeting these timelines to biostatistics management.
• Monitor progress on study activities against agreed milestones and ensure that project deliverables meet the study timelines. Identify out of scope tasks and raise them 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, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
• Follow applicable SOPs, work instructions, and relevant regulatory guidelines (e.g., ICH).
• Maintain well organized, complete, and up to date project documentation, 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.
• Co achieve and mentor other biostatistics staff.
• Perform other work related duties as assigned.
• Minimal travel may be required.

Qualifications

• Must be located in the UK, Ireland, Poland, Greece, Hungary, Romania, Ukraine, South Africa, Belgium, or the Netherlands.
• Previous clinical experience within clinical trials is required.
• CVs should be submitted in English.

Equal Employment Opportunity

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 is committed to compliance with the Americans with Disabilities Act, providing reasonable accommodations when appropriate to assist employees or applicants in performing the essential functions of the job.