Senior Principal Programmer, MA China

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.

Accountabilities:

• In collaboration with stat TA head, TA lead and Medical Manager, or DM 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 learned
• Set 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 deliverables
• When needed, represent AZ to Health Authorities and Reimbursement/Payer Organizations for specific programming related items
• Plan, 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 deliverables
• Promote 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 needed
• Lead/Support team to work across global & functional boundaries, with the ability of expert problem solving and conflict resolution

Qualifications:

• MSc or higher degree in Mathematical, Statistical, Computer Science or Life Science or equivalent experience
• 7+ years of working experience in the Pharmaceutical industry
• Extensive SAS programming expertise to an expert level
• Expert knowledge of CDISC standards and industry best practices
• Comprehensive knowledge of technical and regulatory requirements with submission experience
• In-depth knowledge of statistical concept and relevant scientific knowledge within therapeutic area
• Proven statistical programming leadership experience and in-depth knowledge of programming practices (including tools and processes)
• Ability to lead complex set of deliverables with effective implementation and completion
• Collaborative and effective in working with global & across functional boundaries both internally and externally
• Strong problem-solving skills and conflict resolution
• Leadership skill to lead and direct elements of project work
• Excellent communication skills and ability to influence stakeholders
• Embraces and endorses change and ability to perceive and analyze the big picture
• Other programming languages are preferred e.g. R, S-PLUS, Python, XML etc
• Basic knowledge of lifecycle of drug development
• Basic knowledge of clinical development plan
• Familiar with regulatory policy and guidance in drug development
• Open mind to cutting-edge technology, such as Machine Learning/Deep Learning

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.