Senior Biostatistician

About the role

At ICON Strategic Solutions, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

That's our vision. We're driven by it. And we need talented people who share it.
If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

For the expansion of our team, we are looking for Senior Biostatisticians who will support the business of a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics.

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