Principal Statistical Programmer Oncology
Location: Gaithersburg (US)
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 lead related activities of the analysis and reporting process including, but not limited to, CSR development, regulatory submissions, commercialization and the scientific utilization 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.
Bachelor's Degree in a Statistical or 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
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
AstraZeneca is a global science-led biopharmaceutical company specializing in the discovery, development, manufacturing, and marketing of prescription medicines.