Principal Programming Leader
At AstraZeneca every one of our employees makes a difference to patient lives every day. Each one of us believes that science has the ability to change lives and that to deliver this takes many people with many skill sets. When we deliver a life-changing medicine, that success comes from the combined efforts of all of our people.
As a Principal Programming Leader within the Cardiovascular, Renal and Metabolism therapeutic area, you will Supervise all programming related activities of the analysis and reporting process including, but not limited to, CSR development, regulatory submissions, commercialization and the scientific utilization of our data for AstraZeneca products.
You will work in the Programming department that not only oversees and delivers the programming aspects of analysis and reporting but also manages and maintains our end to end standards and our analysis and reporting production tools.
If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.
Main Duties and Responsibilities
Reporting to an Associate Director/Director within the Statistical Programming group you will lead the programming support in one or more of the following areas:
- Act as the strategic statistical programming leader across one or more Cardiovascular, Renal and Metabolism projects
- Lead the delivery of CSR SDTM/RDB databases and TFL outputs through both internal and external delivery models
- Lead the statistical programming deliverables for regulatory submissions including specification and delivery of overview databases, outputs and response to regulatory questions
- Overseeing the quality of all statistical programming deliverables, holding internal team members, partners and providers accountable for the quality of their deliverable
- Determine accurate resourcing figures
- Produce and maintain technical database standards and programming specification documents
- Identify opportunities to improve the methodology and provide practical solutions for problems
- Contribute to the development of best practice to improve quality, efficiency and effectiveness
- Development Safety Update Reports (DSUR)
- Periodic Benefit-Risk Evaluation Report (PBRER)
- Investigators brochures (IB)
- Planning and executing the transfer and analysis of data for safety/efficacy monitoring boards/independent data monitoring committees
- BSc in Mathematical (i.e., Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science
- Extensive SAS programming expertise to an advanced level
- Comprehensive knowledge of technical and regulatory requirements related to the role
- Knowledge of CDSIC standards and industry best practices
- Extensive experience in clinical drug development or healthcare
- Experience in Regulatory submissions
- Excellent verbal and written communication skills and influence stakeholders
- Lead the development and delivery of training
- Advanced to expert verbal and written communication and collaboration skills.
- Advanced to expert problem solving and conflict resolution.
- Drive others to work across global & functional boundaries.
- Ability to apply programming knowledge and skills to problems, problem solving, and quality focus. Troubleshoots for team.
- Contributes to defining business processes and accurately completes and manages associated documentation.
- Team commitment: prioritise attendance at appropriate project team meetings; take steps to understand and appreciate the roles, skills and strengths of others on the team.
- Diligence – attention to detail and ability to manage concurrent projects and activities within those projects.
- Other programming languages e.g. S-PLUS, R, XML etc
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
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.