Director, Statistician
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
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.
