Principal Statistician

Experteer Overview

In this role you will drive statistical activities for global clinical trials and lead SAS programming teams. You will coordinate with statisticians, data managers and vendors to deliver analyses, SAPs and datasets that meet CDISC ADaM standards. You’ll review deliverables, train statisticians, and support audits and quality systems. You’ll partner with cross-functional teams to inform study decisions and contribute to the department’s scientific and regulatory goals. This is a high-impact position within a growing CRO that aims to be the best in its field.

Retribuzione / Benefits

• Act as a communication line for project teams, clients, vendors and internal team on statistical questions
• Conduct statistical analyses for clinical trials including interim, final analyses, DSMB/DMC, and PK analyses
• Develop and review study protocols, SAPs, and dataset specifications per CDISC ADaM and project documents
• Review statistical deliverables such as tables, figures, listings and analysis datasets
• Conduct departmental induction and project-specific training for statisticians and SAS programmers
• Prepare for and attend audits related to Statistics and participate in audit follow-ups
• Provide input to SOPs and Quality System Documents for Biostatistics
• Liaise with Data Management on statistical data issues
• Participate in bid defense and project kick-off meetings
• Lead teams of SAS programmers and/or statisticians on the project level

Responsabilità

• MSc in Statistics or equivalent
• Full working proficiency in English
• Expert knowledge of statistical principles and methods used in clinical research
• Expert knowledge of SAS programming
• Expert knowledge of CDISC ADaM standard
• Expert knowledge of adaptive designs
• Expert knowledge of sample size calculation
• Knowledge of relevant regulations and guidelines (FDA, EMA, ICH)
• Ability to apply advanced statistical techniques and interpret complex results
• Ability to consult with clinical investigators and determine analysis strategies
• Strong presentation and communication skills