Senior Director, Biostatistics

This Senior Director, Biostatistics role leads a global team of statisticians to shape the design, delivery and interpretation of clinical programs, internal governance decisions and regulatory submissions. The work focuses on bringing rigorous statistical thinking to rare disease drug development, from early strategy through to reimbursement and commercialisation. How will your expertise in biostatistics influence the next generation of life-changing medicines?

You will be responsible for:  

• Lead, manage and develop a group of statisticians 

• Leadership to biostatistics staff world-wide  

• Ensures drug projects are successfully delivered by leading biostatistics support and strategy. This includes Development Plans, Regulatory Strategy and Submissions, high level internal governance committees, Health Technology Assessment and Reimbursement/Payer and Commercial support as appropriate for the stage of the product.  

• Leadership to staff on the product world-wide so that all work is carried out with regards to Alexion standards and external regulations  

• Develop contacts with international and external opinion leaders, consultants, and collaborative groups  

• Provide leadership and direction to improvement projects/activities/initiatives 

• Identify & drive the development & utilization of leading-edge statistical methodology, skills, capabilities, tools, processes & best practice, in order to add value to drug development  

• Lead biostatistics resourcing to deliver projects and input on internal vs outsourcing delivery  

• Maintain understanding and awareness of, as well as investigate and implement, new methodologies, therapy area and development advances  

• May represent Alexion and biostatistics to Health Authorities and Reimbursement/Payer Organizations or high level internal governance committees for specific projects/indications  

• Competent program and project leadership 

• Work according to agreed functional and regional Safety, Health, and Environment (SHE) strategy by ensuring proper management of SHE risks, incidents, reporting, follow-up and improvements  

You will need to have: 

• MSc/PhD in Statistics, Mathematics (containing a substantial statistical component), or recognized equivalent to stats MSc 

• Track record of background in leading independently 

• In depth knowledge of technical/regulatory requirements with 10 years experience in pharm/healthcare 

• Exemplary technical skills 

• Excellent communication skills and ability to build strong relationships 

• Flexible, well-organized, and possess the ability to work well under pressure