The Principal Standards Developer is primarily responsible for leading the technical development, management and maintenance of AZ end-to-end Clinical Analysis & Reporting Standards (SDTM, ADaM, TLFs)) with quality and timeliness, following established standards and processes. This position requires high technical skill and excellent industry knowledge to lead and perform the standards tasks. Acts as subject matter expert. Specific activities may include facilitating raw data standards being mapped to SDTM, managing SDTM and ADaM standards within the metadata repository, leading an initiative to upgrade the controlled terminology catalogue, and monitoring the Data Analysis and Report Standards Helpdesk.

Typical Accountabilities

• Leads and/or directs AZ end-to-end clinical data standards
• Technical subject matter expert in specialised area of  analysis and reporting clinical standards (e.g. clinical coding, clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs))
• Leads quality of own deliverables and oversees quality of other developers standards deliverables
• Drives standards development and implementation within the business
• Identifies opportunities to improve process & methodology and provides practical solutions for problems
• Contributes or leads cross-functional or process improvement initiatives
• Drives the development of best practices to improve quality, efficiency and/or effectiveness within function
• Provides input to standards strategy and leads the implementation of strategy components to meet the evolving internal and external landscape
• Leads standards governance and best practice
• Can contribute to external industry standards and governance groups
• Collaborates and contributes within internal clinical standards governance groups

Essential

• BSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science or equivalent experience
• Expertise in specialised analysis and reporting standards development skills (e.g. clinical coding, clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs)) or expertise in Biometrics functions (e.g. Programming, or Statistics)
• Excellent knowledge of industry standards (e.g., CDASH, SDTM, ADaM)
• Ability to apply standards expertise to problem
• Excellent communication skills in both written and spoken English
• Strong project management skills
• Ability to mentor, train and lead teams
• Thorough knowledge of the clinical development process
• A clear demonstration of behaviours of truth seeking rather than success seeking
• Agile responsiveness to industry and business needs
• Embracing of peer review

Desirable

• Understanding of programming languages other than SAS (eg, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Pearl)
• Ability to influence relevant stakeholders on standards related items
• Ability to manage risk
• Ability to line manage

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.