Oversees and delivers the programming aspects of clinical development, manages and maintains the end to end standards and manages and maintains the Analysis and Reporting production tools and the information infrastructure.  Oversees and delivers the programming contribution to internal decision making, regulatory submissions and reporting and commercial activities for the TA portfolio of projects. Leads, manages and develops a group of programmers.

Typical Accountabilities:

Leads, manages and develops a group of programmers, provides input to the strategy of the Programming function, and provides strategic, scientific and programming advice and expertise to the team.In collaboration with stat TA head, programming TA lead, or programming head, to lead the strategic and operation planning of the programming contributions to the Development Plans, Regulatory Strategy and Submissions, Health Technology Assessment and Commercial support of AZ products.Provide programming leadership on the product so that all work from China team is carried out with regards to AZ standards and external regulations.Collaboration with AZ Counterpart and other TA team members to ensure alignment to corporate and TA standards and ensure implementation of functional best practice and lessons learnedSet high standards (and enforcing compliance) for programming work within the product. Provide programming expertise and leadership in driving high quality decision support. Provide oversight and work with team members to hold CRO/Partners accountable for the high-quality standards of their deliverablesWhen needed, represent AZ to Health Authorities and Reimbursement/Payer Organizations for specific programming related itemsPlan, lead, and perform activity to ensure quality programming study deliverables, ensure accuracy, effective implementation and completion of reporting objects for regulatory submissions or similarly complex set of deliverablesPromote team development by proactively seeking out alternative points of view, providing a role model for others, building cooperation, and motivating others.Leadership on the development of best practice and operational excellence. Development plans and strategy for improvement neededLead/Support team to work across global & functional boundaries, with the ability of expert problem solving and conflict resolution

Education, Qualifications, Skills and Experience

MSc or higher degree in Mathematical, Statistical, Computer Science or Life Science or equivalent experience7+ years of working experience in the Pharmaceutical industryExtensive SAS programming expertise to an expert level and expert knowledge of CDISC standards and industry best practicesComprehensive knowledge of technical and regulatory requirements with submission experienceIn-depth knowledge of statistical concept and relevant scientific knowledge within therapeutic areaProven statistical programming leadership experience and in-depth knowledge of programming practices (including tools and processes), to explore new things/ways of working to drive for impact, comfortable with ambiguity when facing uncertainties.Ability to lead complex set of deliverables with effective implementation and completionCollaborative and effective in working with global & across functional boundaries both internally and externallyStrong problem-solving skills and conflict resolutionExcellent communication skills and ability to influence stakeholdersEmbraces and endorses change and ability to perceive and analyze the big pictureOther programming languages are preferred e.g. R, S-PLUS, Python, XML etcKnowledge of lifecycle of drug developmentKknowledge of clinical development planFamiliar with regulatory policy and guidance in drug developmentOpen mind to cutting-edge technology, such as Machine Learning/Deep Learning

Date Posted

30-4月-2025

Closing Date

29-8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.