Senior Statistician

About This Role

This Senior Statistician role requires an experienced professional to work independently in the pharmaceutical industry, focusing on the design, delivery, and interpretation of preclinical studies, regulatory submissions, and commercialization activities. The individual will perform and communicate complex analyses, guide less experienced staff, and develop creative statistical approaches to their work.

Responsibilities

• Provide statistical expertise for complex design and interpretation for preclinical or clinical programs, high-level internal governance committees, regulatory submissions, and/or commercialization
• Analyze internal and external information, perform modeling and simulation to inform design decisions and the development of decision criteria
• Develop a Statistical Analysis plan for complex studies and/or project deliveries
• Act as a coach/guide for less experienced statisticians in the production of analysis, supporting graphics and analysis tables for study reports, Global Medical Affairs studies or publications
• Analyze, interpret, summarize, and communicate results of complex studies
• Contribute to regulatory submissions, including specification of overview documents and response to regulatory questions
• Identify opportunities for the application of modeling and simulation to improve study design
• Identify opportunities to improve the methodology and provide practical solutions for problems
• Identify and apply statistical methodology to improve the process and delivery activities
• Contribute to the development of best practice to improve quality, efficiency, and effectiveness
• Be accountable for the quality of statistical work; provide discipline-specific understanding, insight, and constructive challenge and take ownership of development needs, seek coaching or training opportunities
• Produce pragmatic solutions, often within a tight time scale where the emphasis is to deliver first, then refine and develop solutions thereafter
• Draft statistical analysis plans for complex studies
• Provide consultancy within area of expertise to fellow statisticians working within therapeutically aligned statistics groups, as well as medical scientists and other key roles across the business
• Investigate and apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration
• Investigate and improve statistical approaches, establish standards and best practice, develop and implement new methodology interacting with external scientists
• Identify new areas where value can be added, developing collaborative relationships with the external scientific/academic community and maintaining academic links
• Contribute to/or lead the development of a process improvement and/or capability area within the Department