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

Essential:

MSc/PhD in Statistics，Mathematics, or other related data science majorsKnowledge of the technical and regulatory requirements related to the roleExperience of regulatory interactions and/or submissionsExcellent communication skills and ability to build strong relationshipsCollaborative - has the energy to work with global & across functional boundaries both internally and externallyAbility to apply statistical expertise to complex problems, problem solving and quality focusMinimum 8 years of industry experienceLeadership skill to lead and direct elements of project workAccountable for the statistical work

Desirable:

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 is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】

Date Posted

24-2月-2025

Closing Date

29-6月-2025

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 authorization and employment eligibility verification requirements.