Senior Biostatistician at ICON plc

As Senior Biostatistician, you will execute diverse statistical tasks supporting the clinical development programs. The tasks mainly focus on guarantying by means of thorough review outstanding statistical quality. You will be involved throughout the full clinical trial process, from study design and protocol writing, over defining the statistical analyses (SAP) to reviewing all study outputs and the corporate social responsibility.

What you will be doing:

• Serve as the responsible biostatistician on clinical trials.
• Contribute to clinical study synopses and protocols.
• Develops Statistical Analysis Plans and/or performs senior quality review of statistical analysis plans
• Review and interpret results from simple to complex clinical studies.
• Provide relevant input in the development and review of CRFs.
• Performs lead review and sets up QC of TFL’s
• Perform critical review of derived datasets specifications and derived datasets (ADaM).
• Contribute to clinical study reports.
• Review simple to complex randomization specifications and dummy randomization schemes.
• Participate in bid defense meetings.
• Contributes to press releases and scientific papers.

You are:

• Master’s degree in statistics or biostatistics required.
• Minimum of 6-8 years of biostatistical experience desired.
• Clinical experience is mandatory
• Exhibit expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
• Thorough knowledge of and experience with CDISC standards is desired.
• Demonstrate ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
• Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study.
• Auto-immune and/or oncology clinical study background is a plus.
• Experience in managing vendors is a plus