Head of Oncology Programming
Head of Oncology Programming
Location: Gaithersburg, South San Francisco, Boston, Cambridge (UK)
At AstraZeneca when we see an opportunity for change, we seize it and commit real resources to make it happen, because an opportunity no matter how small can be the start of something big. Delivering life-changing medicine is about being entrepreneurial - finding those moments and recognizing their potential. Big success can come from seeing potential in something small. We empower our people to seek these out, and we support them to pursue the opportunities they find.
Oncology Programming is the business unit that coordinates and delivers all the statistical programming contributions to internal decision making, regulatory submissions, scientific exchange/publications and commercial activities for Oncology portfolio of projects from early to late phase and post launch.
Reporting into VP Biometrics Oncology, we are seeking a Head of Programming, leading a function of approx 200 people. This role can be based in one of our US sites in Gaithersburg, Boston, SSF, or in Cambridge, UK.
In the role, you provide strategic direction and leadership for the R&D Oncology Programming function. You have significant input to overall strategy of Data Flow and Data Sciences in the delivery of our delivery. You are accountable for continuous improvement and transformational change in pipeline delivery aspects of analysis and reporting component. You are recognised as a leader with vision and a track record within your own area of specialisation internally and externally.
- Lead, manage, and develop a group of statistical programming directors and their teams of early and late phase research as measured by overall quality, delivery, risk management, and adherence to AstraZeneca and external requirements.
- Ensures a coordinated and consistent approach to the specification and presentation of analysis ready information and integration of the data across all projects utilizing current standards and practices.
- Ensures consistent approaches to data standards and integration through expert information management and leadership, as well as utilization of standard methodologies to improve the value and contribution of Programming across the R&D units and Therapy Areas (TAs).
- Leads the TA Standards team and TA Standards and Automation Leaders to develop, implement, and champion therapy area standards & automation for data collection, integration and reporting.
- Accountable for provision of TA data to colleagues in other parts of AZ, collaborations with external parties, acquisitions and divestments.
- Contributes expertise to ensure outsourcing strategies are developed and executed to maintain the highest level of quality as regards TA Biometrics deliverables.
- Leads development strategies, provides expert advice and influence, and/or leads AstraZeneca’s response to complex issues in statistical programming, submissions, and clinical data standards for legacy, current and prospective drug projects within AZ drug development.
- Collaborates with other Drug Development and Information Technology Leaders to maintain consistent programming approaches, processes, and tools across R&D units to overcome challenges both from internal and external sources.
- Uses expertise and knowledge of global issues and trends to define strategic objectives related to statistical programming, clinical data standards, and associated technology, for inclusion into AstraZeneca’s annual business objectives.
- Manages the development of the functional leadership team in area of expertise, and influences and shapes the image of the organisation by providing strategic leadership.
- Core member of the Oncology Biometrics Leadership Team and the cross functional working group (at the R&D unit level)
Education, Qualifications, Skills and Experience
- BSc in mathematics, statistics, engineering, computer science, or life or social sciences (postgraduate degree preferred).
- Extensive statistical programming experience in Pharmaceuticals/Healthcare and/or Clinical Drug/Medical Device Development, ideally within Oncology
- Expert knowledge of clinical data standards (e.g., CDASH, SDTM, ADaM) and global NDA/BLA regulatory submission requirements.
- Global line management experience in a statistical programming function.
- Expert collaboration, communication, project/programme, and influencing skills.
- Significant understanding of the overall drug development process from development, launch through life cycle management
- Ability to influence strategically and persuade tactfully to acquire desired outcomes while maintaining effective, positive, organisational relationships
- Able to motivate and empower a diverse team in a matrix organisation and across global & functional boundaries
- Able to manage to budget and efficiency targets/responsibilities.
- background in designing and implementing business processes.
- Diligence – attention to detail and ability to lead a programme of concurrent activities
- Resilience – ability to overcome and empower others in the face of a changing environment
- Experience in leading significant organizational and change processes
Next steps? Apply now!
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.