The Process Owner – Statistics and Programming is accountable for the lifecycle of their assigned process area providing process design, change management, and monitoring user compliance to their allocated area. They are expected to lead standardization of statistics and programming processes from the legacy science units to enable successful transformation to one R&D organisation.

The Process Owner – Statistics and Programming is part of the Business Process Management and Optimisation group in the Process and Enabling Solutions organisation and reports to the Statistics and Programming Process Lead.

Responsibilities:

• Responsible for the process design, development, implementation, maintenance, continuous improvement, and ongoing customer support for the allocated area
• Responsible for lifecycle management of all procedural documents within the allocated area, and for ensuring compliance with applicable industry regulations and AstraZeneca Global and Local Policies
• Responsible for the effective and timely communication of information, and for the development and delivery of high-quality training materials for the allocated area
• Responsible for providing training, advice and end user support for the allocated process
• Responsible for monitoring performance of the allocated process. Define, track, and monitor key performance indicators and use these data to inform selection of process improvements and input to cross-functional improvements, working in collaboration with the Process Lead.
• Support audit and regulatory inspection planning, preparation and conduct.
• Responsible for the management of Corrective and Preventive Actions (CAPA) on their allocated area to time and quality, and for acting on data or trends identified through the Quality & Risk Management process.
• Partner with the Communities of Practice for Biometrics, Directors of Statistical Standards, and other Process Owners to assess and integrate the statistics and programming processes from the three legacy science units (GMD, iMED, and MedImmune) into a harmonised R&D set of processes.
• Provide strategic direction for their processes in collaboration with the Statistics and Programming Process Area Lead (PAL)
• Partner with the Quality Training & Risk Management organisation to develop and deliver training for new processes.
• Engage with senior leaders to obtain consultation and gain agreement on new or modified processes, removing obstacles for harmonisation and global solutions.
• Employ a high level of cultural sensitivity, interactive communication, negotiation and effective collaboration that necessitates considerable tact, discretion and persuasion to obtain desired outcomes while maintaining ongoing professional relationships.
• Exemplify behaviours of truth seeking, affinity for industry best practice, embracing of peer review, and be agnostic to science unit histories yet acknowledgment of its influence on the current dynamic environment

You must meet the essential qualifications and experience listed below:

• Bachelor of Science in an appropriate discipline or equivalent experience
• Excellent writing skills
• A high level of cultural sensitivity
• Leadership skills, including the ability to solve problems that involve many decision makers, build relationships, and develop multiple options/recommendations.
• Knowledge in project management skills.

The following qualifications and experience are desirable:

• Knowledge of analysis and reporting within the pharmaceutical industry, its relevant business processes, clinical trial information, regulations, and guidelines impacting the drug development process
• Experience mapping process, creating procedural documents, and facilitating effective reviews
• Demonstrable experience of driving change through the development of new ways of working to deliver business performance
• Ability to influence and negotiate at all levels to bring business benefit and customer satisfaction, and to gain the trust and respect of Leadership Teams
• Understanding of AZ’s study and submission policies, processes, delivery models, and systems to provide expert advice to staff and stakeholders.
• Experience of utilizing standard process improvement methodologies (e.g. Lean Six Sigma) to identify root causes of process issues and identify areas of process improvement
• Experience in the development and management of Business Process to deliver business performance

Date Posted

Closing Date

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.