Principal Programming Specialist, 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 Principal Programming Specialist within Oncology and Immuno-oncology you act as the technical leader or subject matter expert for the department, therapeutic area, or drug project. Reporting to the Programming Team Leader you will lead and direct elements of the department, Therapeutic area, or project work with accountability for the quality of elements of project programming work worldwide.
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 act as the technical leader or subject matter expert for the department, therapeutic area, or drug project in one or more of the following areas:
- 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.
- The creation of regulatory deliverables including but not limited to:
- Regulatory response to agency queries
- Development Safety Update Reports (DSUR)
- Periodic Benefit-Risk Evaluation Report (PBRER)
- Investigators brochures (IB)
- Data submission strategy, i.e., legacy data, pooling data, communications with regulatory agencies
- Therapeutic area specific analyses
- Outcomes studies/outcomes management
- Payer research/reimbursement
- Standards, e.g., CDISC, Astra Zeneca, governance MDR principles
- Data preparation and analysis for Global Medical Affairs work
- Pharmacokinetics/pharmacodynamics data preparation and analysis
- Manipulating and analysing adjudicated data
- Planning and executing the transfer and analysis of data for data safety monitoring boards/independent data monitoring committees
- Planning and delivering Clinical Trial Transparency (data de-identification)
- Work with the Statisticians to create the randomization schedules for the clinical trials
- Other areas as assigned
- 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
- Subject matter expert in one or more areas of programming within clinical drug development.
- Excellent verbal and written communication skills
- Assist in developing and delivering training in areas of expertise
- 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
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience. 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 - 24th November 2017