Senior Standards Developer
We are looking for a Terminology Standards Developer whose primary focus will be to support the development and maintenance of the AstraZeneca Labcodes Dictionary, providing expertise in terminology management to ensure accuracy and consistency in Clinical Studies, Patient Safety, and across studies so that submission data is of high quality. Experience in working with Laboratory Data, Laboratory Testing, RAVE Lab Administration or CDISC Controlled Terminology for Lab is preferred.
The Senior Standards Developer I is responsible for delivering moderate complexity AZ end-to-end Clinical Analysis and Reporting Standards in their area of expertise (e.g. clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs)) with quality and timeliness, following established standards and processes. Provides solutions for analysis and reporting standards whilst adhering to industry and company standards methodology. This position requires technical skills and adequate industry knowledge to independently perform tasks while using judgement about seeking guidance in complex situations. The Senior Developer I can be responsible for a whole standard deliverable or part of a standard deliverable.
- Develops and maintains one or more median/high complexity analysis and reporting standards (e.g. clinical dictionaries, and data analysis & reporting standards (SDTM, ADaM, TLFs))
- Monitor and updates requests within defined system
- Performs independent quality control
- Leads quality of own deliverables and completeness of applicable quality and process documentation
- Contributes to the development of best practices to develop, maintain and publish data standards consistently
- Collaborates with clinical standards governance groups
- Contributes as a subject matter expert support to drug projects on AZ Clinical Standards
- Assists with metric reporting on standards and requests
- Can contribute to function by training and mentoring
- BSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science or equivalent experience.
- Accomplished in specialised standards development skills (eg, clinical laboratory tests and coding dictionaries, data analysis & reporting standards (SDTM, ADaM, TFLs)) or accomplished experience in Biometrics functions (eg, Programming, or Statistics)
- Knowledge of MS Excel, deep attention to the details and a systematic approach to work
- Good knowledge of the clinical development process
- Good Project management skills
- Good knowledge of industry standards (eg, CDASH, SDTM, ADaM)
- Good knowledge of the structure and application of clinical dictionaries including MedDRA, WHODrug Global, and Labcodes
- Good knowledge of medical terminology and pharmacology as it relates to pharmaceutical drug development and associated regulations
- Good communication skills in both written and spoken English
- A clear demonstration of behaviours of truth seeking rather than success seeking
- Embracing peer review
- Ability to apply clinical data standards technical knowledge to problem solving
- Ability to proactively manage concurrent activities within role
- Understanding of programming languages (eg, SAS, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Pearl)
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 authorisation and employment eligibility verification requirements.