Switzerland
Posted 1 year 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
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
Job Features
Job Category | BIOSTATISTICS, CLINICAL DEVELOPMENT, LIFE SCIENCES |