Senior/Principal Biostatistician, Global Clinical Development

Posted 2 years ago

Key responsibilities:

  • Provide expert statistical input to the design, analysis and interpretation of clinical studies, and development plans, primarily within Oncology
  • Ensure provision of quality and timely statistical analyses results that support quality and timely decision making
  • Lead statistical and programming study teams and perform statistical analyses
  • Provide statistical oversight and guidance to study teams and outsourcing CRO partners, ensuring CROs’ accountability for the quality of their deliverables
  • Represent statistics within cross functional study teams and project sub-teams and provide statistical support and solutions
  • Provide statistical support for briefing books, submissions, health authorities’ requests, publications, and other relevant documents, as assigned
  • Participate in interactions with Health Authorities
  • Maintain current scientific and regulatory knowledge
  • Provide input/lead internal process improvement and/or new statistical capability


  • MSc. or PhD in statistics or related field
  • At least 5 years’ experience as project/study statistician in Clinical Development in the pharmaceutical industry
  • Experience of development program design and data analysis working on Oncology studies
  • Strong statistical methodology knowledge and implementation. Experience using Bayesian designs is a plus
  • Proven experience and programming skill in SAS or R
  • Up to date knowledge of regulatory requirements related to statistics
  • Continuous improvement mindset and looking to bring best practices
  • Effective communication and ability to build positive relationships with internal and external stakeholders
  • Team player, looking to be part and contribute to the team success

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