Principal Standards Developer

Location(s) – Gaithersburg (US); Permanent

Salary - Competitive salary and company benefits apply

Would you like to be a part of a Programming department 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. 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. Join AstraZeneca as a Principal Standards Developer in Biometrics & Information Sciences (B&I) and you will play a key leadership role providing Clinical Data Standards subject matter expertise to support the delivery of our exciting drug development portfolio within the Global Medicines Development (GMD) organisation. 

Within AstraZeneca, our Biometrics & Information Sciences (B&I) department is an integral part of Global Medicines Development (GMD) and drives excellent design in order to generate the data required 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.

The Standards Development and Maintenance team (SD&MT) within the Programming department of B&I, develops and maintains end to end Clinical Data Standards (from raw data standards to Tables, Figures and Listing standards) at the Corporate and Therapy Area (TA) level and manages Standards related processes, training and clinical dictionaries

As a Principal Standards Developer, you will be a key member of the SD&MT and will be contributing to defining, developing and governing the end to end Clinical Data Standards. You will be involved in defining the strategy for the adoption and implementation of industry wide standards and will have the opportunity to represent AstraZeneca on industry level standards teams (CFAST, CDISC, PhUSE). You will have a key role in the implementation and use of an industry leading Standards Metadata Repository at AZ. With our outstanding drug portfolio, new Analysis and Reporting Technology system and robust Standards Strategy, it is an exciting time to join AstraZeneca and further your Clinical Data Standards focused career.

Responsibilities

Reporting to the Director, Standards Development & Maintenance Team, you will provide support in one or more of the following areas:

• Develops and maintains AZ Clinical Data Standards at the Corporate and TA level including Raw Data, SDTM, ADaM, and output standards
• Resolves standards issues within and across strategic partnerships and escalates appropriately unresolved issues with recommendations for change
• Supports the training activities for Clinical Data Standards and the development of associated documents (procedural and technical documents)
• Supports the TA Standards Definition Team(s) as needed
• Responsible for managing change control, publication and communication of Clinical Data Standards
• Provide expert input on process for standards
• Provide expert input on CDISC standards, metadata management and the end to end alignment of Clinical Data Standards and their application in drug projects
• Serve as point of contact for Alliance Partners and lead the provision of standards consulting expertise to external partners on adoption and application of standards for AZ studies
• Provide input to the standards strategy and lead the implementation of strategy components to meet the evolving internal and external landscape.

Your Knowledge, Skills & Experience

As a Principal Standards Developer, your career will demonstrate...

• Broad understanding of the clinical drug development process
• Excellent knowledge of CDASH/SDTM/ADaM CDISC Standards and the end to end alignment of Clinical Data Standards and their use in drug project
• Excellent communication and collaboration skills – experience in working across global and functional boundaries
• Ability to apply expertise to problems, problem solving and quality focus
• Experience of clinical database development and reporting
• Knowledge of technical and regulatory requirements related to the role
• Experience in authoring of procedural and guidance documents
• SAS programming knowledge preferred

Education: Your career will be built on a BSc or post graduate qualification (or local equivalent) in Mathematics, Statistics, Computer Sciences or Life Sciences.

Opportunities to Grow with AstraZeneca

• Play a role in delivering our vision for Programming
• Contribute to building end to end standards driven automation
• Represent Programming at external conference and forums
• Work with outstanding professionals focused on science, quality, and helping patients

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, 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.