Primarily responsible for coordinating the various tools for collecting different types of data. Responsible for ensuring databases are created and adjusted for the end user. Also contributes to the development and maintenance of analysis and reporting applications. Able to solve complex problems within own area and will participate in a range of projects.
Statistical Programmers - Senior / Principal - Oncology / Respiratory / CVRM
Location(s) - Cambridge (UK), Gothenburg (Sweden) or Gaithersburg (US); Permanent
Salary - Competitive salary and company benefits apply
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 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.
You will provide Statistical Programming support and/or lead 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. There are many career options you can pursue for progression including technical pathways, management of global projects or line management.
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.
You'll be part of a global team that pulls together to put patients first.
Reporting to an Associate Director/Director within the Statistical Programming group you will provide programming expertise in one or more of the following areas:
* Lead/Contribute to the delivery of the Clinical Study Report (CSR), Study Data Tabulation Model (SDTM)/Analysis Data Model (ADaM) databases and Tables, Figures and Listings (TFL) outputs through both internal and external delivery models
* Lead/Contribute to the statistical programming deliverables for regulatory submissions including specification and delivery of overview databases, outputs and response to regulatory questions
* Produce and maintain technical database standards and programming specification documents
* Lead/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
To succeed in this role, you'll be an experienced programmer with good knowledge of technical and regulatory requirements related to programming within the pharmaceutical or healthcare industry. You'll enjoy multitasking, collaborating as part of a global team, and have an appetite for solving problems. You will be an effective communicator, with a strong team focus who enjoys collaborating to achieve the best results.
We have several opportunities across both Senior and Principal levels.
Desirable experience includes:
* BSc in a Mathematical (i.e. Applied Math, Engineering, etc.), Statistical, Computer Science or Life Science subject
* Excellent problem-solving skills
* Diligence - attention to detail and ability to manage concurrent projects and activities
* Excellent verbal and written communication skills and ability to influence stakeholders
* SAS programming expertise gained within a clinical drug development or healthcare setting
* Knowledge of CDSIC standards and industry best practices
* Knowledge of database set-up and report publishing requirements
* Extensive SAS programming expertise to an advanced level gained within a clinical drug development or healthcare environment
* Comprehensive knowledge of technical and regulatory requirements with submission experience
* Wide-ranging knowledge of CDSIC standards and industry best practices
* 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
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete your application on our website at your earliest convenience.
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.
AstraZeneca is a global science-led biopharmaceutical company specializing in the discovery, development, manufacturing, and marketing of prescription medicines.