Principal Biostatistician , FSP - Permanent Homebased (m/w/d)

Experteer Overview

Your expertise will shape endpoints, estimands, and analysis strategies, driving high‑quality deliverables across the study lifecycle. This position offers a chance to influence pivotal clinical decisions within a global CRO/industry setting and contribute to patient outcomes through rigorous, compliant statistics.

• Serve as the primary statistical lead on the Clinical Trial Team and represent Biostatistics with professionalism
• Provide independent, proactive statistical guidance throughout the study lifecycle
• Lead statistical strategy discussions, including endpoint definitions, methods, risk mitigation, and regulatory expectations
• Author Statistical Analysis Plans (SAPs) in collaboration with cross‑functional partners
• Apply advanced methods (e.g., time‑to‑event, MMRM, estimands) and ensure regulatory compliant analyses
• Perform or oversee sample size calculations and justify design assumptions
• Collaborate with statistical programmers to ensure SAP–programming alignment and deliverables
• Contribute hands‑on SAS programming and work with clinical datasets; knowledge of R and CRM systems is advantageous
• Participate in CTT meetings, communicate statistical concepts to non‑statistical stakeholders
• Provide clear, influential explanations of statistical approaches to team members

• Advanced degree in Biostatistics or related field (PhD preferred; Master's with significant experience acceptable)
• Proven independent study statistician in late‑phase (Phase II/III) trials
• Experience in pharmaceutical industry preferred; CRO experience a plus
• Hands‑on expertise with cardiovascular outcomes, symptomatic endpoints, and quality‑of‑life measures
• Proficiency in SAS; working knowledge of R advantageous
• Experience with regulatory submissions and health authority interactions a plus

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