Senior Manager, Biostatistics

This Is What You Will Do

Senior Manager, Biostatistics has sufficient experience working as a statistician in the pharmaceutical industry to be working independently on activities relating to clinical trial design, delivery and interpretation, preclinical studies, regulatory submissions and/or commercialization. This individual is able to perform and communicate results of more technical analyses, and able to guide less experienced staff. They have the scope to develop creative statistical ideas and approaches, and to apply them in their work.

Competent individual contributor with excellent cross-functional collaboration.

Senior Manager, Biostatistics has sufficient experience working as a statistician in the pharmaceutical industry to be working independently on activities relating to clinical trial design, delivery and interpretation, preclinical studies, regulatory submissions and/or commercialization. This individual is able to perform and communicate results of more technical analyses, and able to guide less experienced staff. They have the scope to develop creative statistical ideas and approaches, and to apply them in their work.

Competent individual contributor with excellent cross-functional collaboration.

• Provide statistical expertise for complex design and interpretation for preclinical or clinical programmed, high level internal governance committees, regulatory submissions and/or commercialization
• Analyze internal and external information, perform modelling 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
• Able to analyze, interpret, summarize and communicate results of complex studies
• Contribute to the regulatory submissions including specification of overview documents and response to regulatory questions
• Identify opportunities for the application of modelling 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
• Accountable for the quality of their statistical work; provide discipline-specific understanding, insight and constructive challenge and take ownership of development needs, seek coaching or training opportunities

• MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognized equivalent to stats MSc
• 1-2 years of experience in pharmaceutical industry
• Competent statistical programmer (SAS and R)
• Knowledge of key technical and regulatory requirements
• Experience of design, analysis and reporting of preclinical or clinical studies in more than one setting
• Communication skills
• Collaboration and team working skills
• Experience and knowledge of statistical methods and applications in study design, analysis and interpretation
• Flexible, well-organized, and possess the ability to work well under pressure.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

• PhD in Statistics/Biostatistics is preferred.
• Collaboration required
• Ability to apply statistical expertise to problems, and problem solving and quality focus

Joining Alexion means embracing an opportunity where work isn’t ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave,…