Principal Biostatistician at ICON plc

• As Principal Biostatistician, you will execute diverse statistical tasks supporting the clinical development programs. You will be involved throughout the full clinical trial process, from study design and protocol writing, over defining the statistical analyses (SAP) to reviewing study outputs, CSR’s and publications.

What you will be doing:

• Serve as the responsible biostatistician on clinical trials.
• Contribute to clinical study 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).
• Presentation of key results
• Contribute to clinical study reports.
• Review simple to complex randomization specifications and dummy randomization schemes.
• Oversee trials outsourced to Contract Research Organizations from a Biostatistics perspective
• Contributes to press releases and scientific papers.

You are:

• Master’s degree in statistics or biostatistics or related subjects
• 5+ years of experience as a biostatistician in CRO or Pharmaceutical companies
• Thorough knowledge of and experience with CDISC standards
• Previous experience in writing of SAP
• Previous experience in creation of analysis for publications
• Strong communication skills
• Knowledge of ADAM and TFL programming