Principal Statistician - Remote

Overview

The Principal Statistician will contribute to statistical activities related to global clinical trials and work closely with international teams of statisticians, programmers, and data managers.

In Short

• Act as a communication line for project teams, clients, vendors, and internal teams on statistical questions.
• Conduct statistical analysis for clinical trials including interim and final analysis.
• Develop and review study protocols and statistical analysis plans.
• Review statistical deliverables such as tables and analysis datasets.
• Conduct training for statisticians and SAS programmers.
• Prepare for and attend internal and external audits.
• Provide input to standard operating procedures.
• Liaise with Data Management on statistical questions.
• Participate in bid defense and kick-off meetings.
• Lead teams of SAS programmers and/or statisticians.

Requirements

• MSc in Statistics or equivalent.
• Expert knowledge of statistical principles and methods used in clinical research.
• Expert knowledge of SAS programming.
• Expert knowledge of CDISC ADaM standards.
• Expert knowledge of adaptive designs.
• Expert knowledge of sample size calculation.
• Knowledge of relevant regulations and guidelines (e.g. FDA, EMA, ICH).
• Ability to apply advanced statistical techniques.
• Strong presentation and communication skills.

Benefits

• Dynamic and supportive work environment.
• Opportunities for professional growth.
• Engagement in meaningful projects that change lives.
• Comprehensive recruitment process.