Principal Programming Leader, Oncology/Immuno-oncology job in Gaithersburg
|Employer:|| AstraZeneca Pharmaceuticals|
Would you like to be a part of a Programming group who has direct strategic impact on drug development, playing a key role in getting medicines to patients? |
At AstraZeneca every one of our employees makes a difference to patient lives every day. We are building on our strong oncology pipeline and turning ideas into life-changing medicines that benefit patients around the globe.
Within AstraZeneca our Programming group sits within our Biometrics & Information Sciences (B&I) department, which drives good design to generate the data needed for quality decision making on our projects. B&I is an integral part of our Global Medicines Development (GMD) division, the area of our business responsible for late stage drug development - transforming innovative science to medicines.
As a Principal Programming leader within the Oncology/Immuno-oncology therapeutic area, you will Supervise all programming related activities of the analysis and reporting process including, but not limited to, CSR development, regulatory submissions, commercialisation and the scientific utilisation 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 are ready to discover what you can do - join us.
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 Oncology/Immuno-oncology drug 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 effectivenes
•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
To succeed in this role, you will be an experienced programmer who can apply programming knowledge and skills to problem solving, with a focus on quality. You'll enjoy taking the lead on projects and work diligently with great attention to detail and ability to manage concurrent projects and activities within those projects. Your effective communication skills will enable you to influence stakeholders and to collaborate effectively.
•Extensive SAS programming expertise to an advanced level gained within a clinical drug development or healthcare environment
•Comprehensive knowledge of technical and regulatory requirements related to the role
•Knowledge of CDSIC standards and industry best practices
•Experience in Regulatory submissions
•BSc in a Mathematical (i.e. Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science subject
•Travel - willingness and ability to travel domestically and/or internationally
•Team centric approach: keen to take steps to understand and appreciate the roles, skills and strengths of others on the team
•Other programming languages e.g. S-PLUS, R, XML etc.
•Experience leading the development and delivery of training
Location(s) - Cambridge (UK) or Gaithersburg (US)
Salary - Competitive salary and company benefits apply
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 is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender 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 - 13th November 2018