Senior/Principal Biostatistician, Global Clinical Development

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

Requirements:

• 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