Sr-Principal Biostatistician - Medical Affairs (Europe and LATAM ONLY)

Sr-Principal Biostatistician – Medical Affairs (Europe & LATAM)

This role focuses on providing statistical support for medical affairs projects across Europe and Latin America, primarily in diabetes and cardiovascular therapeutic areas.

Job Responsibilities

• This position is open to Europe and LATAM only – CVs should be submitted in English.
• Support two projects in diabetes and cardiovascular; design and implement external control arm analyses, time‑to‑event analyses, and other advanced statistical methods.
• Prepare Statistical Analysis Plans (SAPs) and develop mock‑up displays for tables, listings, and figures.
• Assist with protocol development, randomization schedules, publications, and the clinical study report.
• Coordinate activities of biostatistics and statistical programming personnel to ensure timely completion of high‑quality work.
• Provide independent review of project work produced by other biostatisticians.
• Create or review programming specifications for analysis datasets, tables, listings, and figures.
• Review annotated CRFs, database design and other documentation to ensure protocol criteria are met.
• Participate in verification and quality control of deliverables, ensuring consistency with SAP and specifications.
• Implement company objectives and devise alternative solutions to business and operational challenges.
• Serve as biostatistics representative on project teams, interfacing with other departmental representatives.
• Manage scheduling and time constraints across multiple projects, adapt workloads, and communicate difficulties to management.
• Monitor progress against milestones and ensure study timelines are met; identify out‑of‑scope tasks and report to management.
• Provide statistical programming support as needed.
• May participate in Data Safety Monitoring Board or Data Monitoring Committee activities, serving as an independent non‑voting biostatistician.
• May lead integrated analyses projects, attend regulatory agency meetings, and respond to questions to support statistical analysis results.
• Follow applicable SOPs, WIs, and regulatory guidelines (e.g., ICH).
• Maintain organized, complete, and up‑to‑date project documentation and verification/quality‑control documents to ensure inspection readiness.
• 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.

Additional Information

Tasks, duties, and responsibilities as listed are not exhaustive. The Company may assign other tasks at its discretion. Equivalent experience, skills, and/or education may be considered. The Company complies with the EU Equality Directive and the Americans with Disabilities Act, providing reasonable accommodations when appropriate.