Experteer Overview
As Principal Biostatistician, you lead design, analysis and interpretation of clinical studies and guide statistical outputs and activities. You collaborate with sponsors, PMs, clinical teams, data managers, writers and programmers to ensure timely, high-quality statistical content. You oversee SAPs, summaries and trial design elements, and mentor junior statisticians. You represent biostatistics in audits, bid defenses and cross-functional initiatives, supporting regulatory submissions and product development with up-to-date methods.

Compensaciones / Ventajas
• Act as study lead for multiple or complex studies and programs
• Review and contribute to clinical programs and protocol design sections
• Oversee statistical programming activities and ensure on-time delivery
• Review statistical documents (protocols, synopses, CSR sections) and provide feedback




• Write or review SAPs and output shells; ensure quality and validity of outputs
• Collaborate with cross-functional teams to represent statistical needs
• Review SDTM and ADaM datasets/specifications for quality and appropriateness
• Mentor and support junior statisticians; provide departmental training
• Support audits, bid defenses, and sales activities related to statistics
• Contribute to trial design, regulatory submissions (IND/NDA/BLA, IDE/PMA) and industry best practices
• Maintain project management aspects (financials, timelines) with leadership input
• Represent the function in internal/external meetings and during audits

Responsabilidades
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Requisitos principales
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📌 Principal Biostatistician (Madrid)
🏢 Ergomed Group
📍 Madrid