This role has sufficient experience in the pharmaceutical industry to independently lead a biostatistics team to deliver project and/or technical level activities related to design, delivery and interpretation, high level internal governance committees and/or regulatory submissions. This individual is able to lead, perform and communicate results of more technical analyses, and able to guide and lead less experienced staff. 

Typical Accountabilities:

With high degree of independence and strong statistical leadership, collaborating with cross-functional disease area leads and global counterparts,

• To lead the strategic, statistical thinking and contributions to the Development Plans, Regulatory Strategy, Health Technology Assessment and Commercial Presentation for indications/projects within an AZ product team.  
• To provide statistical leadership on the indications/projects so that all work is carried out with regards to AZ standards and external regulations.  
• To provide statistical leadership in developing design options and providing high quality decision support to enable the business to make informed decisions.  
• To proactively identify and quantify the benefit, risk, value and uncertainty of the emerging product profile. 
• To provide leadership and to ensure effective and efficient way of working in holding CRO/Partners accountable for the high quality standards of their deliverables.  
• To represent AZ and Statistics to Health Authorities and Reimbursement/Payer Organizations for specific projects/indications. 
• To apply expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration.
• To maintain understanding and awareness on new methodologies, therapy area and development initiatives.
• Function effectively as a complex program lead and/or disease area lead in a cross-function setting.
• To plan and to manage resource to ensure drug projects are successfully delivered to quality and time.
• To role model and to provide leadership and direction on the development of best practice in operational excellence and scientific excellence, and to drive continuous improvement.
• To mentor/coach and support the education and training of Statistics staff.
• Develops contacts with international opinion leaders, consultants and collaborative groups.

Education, Qualifications, Skills and Experience

• MSc/PhD in Statistics，Mathematics, or other related data science majors
• Knowledge of the technical and regulatory requirements related to the role
• Experience of regulatory interactions and/or submissions
• Excellent communication skills and ability to build strong relationships
• Collaborative - has the energy to work with global & across functional boundaries both internally and externally
• Ability to apply statistical expertise to complex problems, problem solving and quality focus
• Minimum 8 years of industry experience
• Leadership skill to lead and direct elements of project work
• Accountable for the statistical work
• Experience in leading registration studies through the regulatory filing (e.g. protocol design, data analysis, NDA preparation and regulatory interaction for NMEs)
• Knowledge of compound, disease and regulatory guidance