Principal Biostatistician, FSP

• Lead statistical activities for assigned Clinical Trials (Phases 1 to 4) independently from protocol design to reporting of results.
• Represent Statistics function on cross-functional trial and possibly indication/project teams.
• Collaborate effectively with all cross-functional stakeholders.
• Oversee internal programming activities and/or CRO contributions on assigned clinical trials.
• Contribute to or lead Safety Reporting, ISS/ISE, responses to Health Authorities, and Publications.
• Use SAS and/or R for QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, and exploratory analyses.
• Contribute to initiatives at Cytel or sponsor side.
• Provide oversight of more junior Statisticians.
• Formulate integrated analytical approaches using statistical methods, machine learning, and deep learning algorithms to discover actionable insights and automate recurring processes.

• Minimum of Bachelor's degree in statistics or a related discipline.
• 9+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
• Ability to work independently, demonstrate initiative and flexibility through effective and innovative leadership.
• Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviours.
• SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.
• Knowledge of R programming (R Shiny/Python).

• Consistent training, development and support
• Significant professional growth
• Autonomy and ownership in work
• Support from Cytel while embedded with a pharmaceutical client