Global Project Programmer, Oncology and Immuno-oncology
Location(s) - Cambridge (UK) or Gaithersburg (US); Permanent
Salary - Competitive salary and company benefits apply
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.
At AstraZeneca our Biometrics & Information Sciences (B&I) department is an integral part of Global Medicines Development (GMD) and drives good design to generate the data needed for quality decision making. The goal of B&I is to deliver value to the pipeline by excellence in delivery, improving decision making, and engaging and shaping the external environment whilst accessing and implementing innovative solutions.
As the Global Project Programmer within Oncology and Immuno-oncology you will provide support for all aspects of the clinical development process including, but not limited to, clinical development plans, regulatory submissions, programming and information deliverables, commercialisation and scientific utilisation data for AstraZeneca products.
You will work in in the Programming department that 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.
The Oncology/Immuno-oncology Therapeutic Area (TA) programming group oversees and delivers all the programming contribution to internal decision making, regulatory submissions and reporting and commercial activities for the portfolio of projects within Oncology.
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 the Associate Director (Programming Team Leader) you will lead programming support for regulatory submissions including the specification and delivery of overview data bases, output, payer research, and response to regulatory questions.
You will act as the strategic statistical programming leader who leads 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. This will include overseeing the quality of all deliverables, holding partners and providers accountable for the quality of their deliverable.
You will work to improve quality, efficiency and effectiveness by contributing to the development of best practice and identifying opportunities to improve the methodology, providing practical solutions for problems.Essential Requirements
- 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.
- Travel - willingness and ability to travel domestically and/or internationally.
- 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.
- Extensive knowledge of Open CDISC Validator
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 is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
Closing date for applications - 30th December 2017