Principal Biostatistician FSP

Responsibilities

• Lead statistical activities for assigned Clinical Trials (Phases 1 to 2) independently from protocol design to reporting of results.
• Represent Statistics function on cross-functional trial (and possibly indication / project) teams and collaborate effectively with all cross-functional stakeholders.
• Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
• Contribute to or lead other activities from a statistical perspective as appropriate, including but not limited to Safety Reporting, ISS/ISE, addressing questions from Health Authorities, Publications.
• Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.
• Contribute to and participate in other initiatives at Cytel or sponsor side as appropriate.
• Oversight of more junior Statisticians as required.

Qualifications

• 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).