Description
Principle ProgrammerThe Principle Programmer will be responsible for delivery of the technical components required to support the analysis and reporting for a complex project as defined in the Clinical Development Plan (CDP) and Clinical Project Information Plan (CPIP).
They will provide broad expertise in all aspects of the Programming field. This will be in accordance to Standard Operating Procedures (SOPs) and applicable regulatory guidelines. A complex project may be a large, global project involving many different phases or a new and novel therapeutic area. The Principal Programmer may contribute to the development and maintenance of applications used for analysis and reporting purposes.
Candidate Focus & Challenge
- Lead the application of computer science and information technology methods to provide the technical components that support all aspects of the clinical development process, including clinical development plans, regulatory submissions, commercialisation and scientific utilisation data for AZ products
- Provide strategic input and leadership to the delivery of all technical programming and information components of a project
- Lead the provision of technical consulting expertise to external partners in relation to the specification and delivery of the SDTM and RDB databases by these partners
- Oversee the quality of all deliverables, holding partners and providers accountable for the quality of their deliverable
- Lead programming support to the regulatory submissions including specification and delivery of overview data bases, output and response to regulatory questions
- 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
Candidate Knowledge, Skills & Experience
- Proven leadership capabilities
- BSc in Mathematical, 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
- Experience of Regulatory submissions
- Communication skills
Job Dimensions
- Leadership role able to lead and direct project work
- Accountable for the quality of elements of project programming work worldwide
- Accountable for good Information Practice
- Reports to TA Programming Director
Other
- Excellent collaboration required - needs the energy to work across global & functional boundaries
- Ability to apply programming expertise to problems, problem solving and quality focus.
- Other programming languages (e.g., S-PLUS, R, etc.)
If you are interested in this role, have any questions about this position or would like to register your interest in other positions, please feel free to send your up to date CV or contact Oliver Davies on