Executive Director, Biostatistics Rare Disease

This is what you will do:

The Executive Director, Biostatistics has extensive experience in the pharmaceutical industry to independently lead a therapeutic area biostatistics team (e.g. Neurology, Hematology/Nephrology, or other) to deliver project, tools and/or technical level activities related to design, delivery and interpretation, advises statisticians across business units to prepare for high level internal governance committees and/or regulatory submissions.

You will be responsible for:

• Lead and supervise an efficient and effective Biostatistics team. Manage performance of direct reports, ensure development and succession planning. Provide coaching and feedback to foster professional development while also supporting business goals
• Serve as an internal statistical expert/consultant across the business unit for own area of expertise
• Coordinates the review of any new proposed external regulatory guidelines where statistical expertise input is needed and serves as the statistical representative on cross functional reviews of such guidance documents
• Influences and develops contacts with international opinion leaders, consultants, and collaborative groups
• Provide leadership and direction to improve internal and external projects/activities/ initiatives, e.g. study design consultations and specialized statistical expertise for ongoing and completed studies
• Strong external presence. Known by other experts in their field. Invited speaker and chair at multiple major conferences/groups. Leader of an external working group, e.g. PSI special interest. Author of multiple key publications.
• Uses expertise to develop strategy & actionable plans for addressing future business needs both within Alexion and externally
• Identify & drive the development & utilization of leading-edge statistical methodology, skills, capabilities, tools, processes & best practice, in order to add value to drug development
• Work with the VP of Quantitative Statistics on overall analytics strategy, and provide senior level technical expertise regarding statistical capabilities & solutions
• Develop collaborative relationships with the external scientific/academic community
• Steer & support development & maintenance of any required tools & processes in a manner that meets regulatory and evidential requirements
• Communicates new methodology externally through workshops and training
• 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:

• Managerial experience
• MSc in statistics or relevant topic with relevant clinical trial and/or pharmaceutical industry experience
• Track record of background in leading independently
• In depth knowledge of technical/regulatory requirements with experience in pharm/healthcare
• Exemplary technical skills
• Excellent communication skills and ability to build strong relationships
• Excellent collaboration required – needs the energy to work across global & functional boundaries both internally and externally
• Vision – keen awareness of R&D priorities in order to apply novel solutions to scientific problems
• 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.
  
  
  

We would prefer for you to have:

• PhD in Statistics/Biostatistics is preferred.
• Experience in rare diseases