Experteer Overview

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In this role you drive biostatistics for clinical trials as the primary statistician on projects. You collaborate with cross-functional teams, clients, and vendors to address statistical questions and shape study design. You author and review protocols, analysis plans, SAS specifications, and data structures to ensure robust analyses. You lead programming, validation, and deliverables while ensuring regulatory alignment and audit readiness. You contribute to the company’s mission to be a world-class CRO by delivering accurate, impactful statistical insights.

Compensaciones / Ventajas
• Lead biostatistics activities as responsible project statistician
• Communicate statistical questions with project teams, clients, and vendors
• Develop/review protocol sections including sample size calculations
• Develop statistical analysis plans
• Develop and document analysis database structures (SAS EDW)
• Develop SAS program requirements and specifications




• SAS programming and program validation
• Review QC of statistical deliverables (tables, listings, figures)
• Perform statistical analysis and report results
• Consult on experimental design and statistical methods for safety/efficacy
• Liaise with DM on data issues and data transfers to Statistics
• Participate in bid defense and kick-off meetings
• Train statisticians and SAS programmers
• Prepare and deliver presentations at investigators' meetings
• xqbhyrx Address and resolve audit findings

Responsabilidades
• MSc in Statistics
• Expert knowledge of statistical principles used in clinical research
• Ability to apply advanced statistical techniques for clinical studies
• Ability to consult with clinical investigators and determine analysis strategies
• Expert knowledge of SAS programming
• Expert knowledge of CDISC ADaM
• Knowledge of FDA, EMA, ICH guidelines
• English proficiency

Requisitos principales
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📌 Senior Statistician (Madrid)
🏢 PSI Software
📍 Madrid