Principal Biostatistician at ICON plc

As a Principal Biostatistician you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

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:

• PhD in statistics or biostatistics or related subjects and 5+ years of experience as a biostatistician in CRO or Pharmaceutical companies OR Masters degree in statistics or biostatistics or related subjects and 10+ years of experience as a biostatistician in CRO or Pharmaceutical companies
• Thorough knowledge of and experience with CDISC standards
• Thorough knowledge of and experience in Regulatory
• Previous experience in working on Phase 2 and 3 studies
• Previous experience in R programming, ESTIMANDS and adaptive designs
• Previous experience in writing of SAP
• Previous experience in creation of analysis for publications
• Strong Leadership and Communication skills
• Knowledge of ADAM and TFL programming