Senior Standards Developer

2 weeks ago


Bengaluru, Karnataka, India AstraZeneca Full time

This position will be responsible for delivering AZ end-to-end Clinical Analysis and Reporting Standards in the area of A&R (raw data standards to SDTM mapping, support/management SDTM and ADaM standards within the metadata repository) with quality and timelines, 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 can be responsible for a whole standard deliverable or part of a standard deliverable.

Typical AccountabilitiesDevelops and maintains median/high complexity analysis and reporting standards (SDTM, ADaM)Monitor and updates requests for A&R Standards updates within defined systemPerforms independent quality controlLeads quality of own deliverables and completeness of applicable quality and process documentationContributes to the development of best practices to develop, maintain and publish data standards consistentlyCollaborates with the other team members in the clinical standards governance groupsContributes as a subject matter expert support to drug projects on AZ Clinical StandardsAssists with metric reporting on standards and requestsCan contribute to function by training and mentoringEducation, Qualifications, Skills and ExperienceEssentialBSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science or equivalent experience.

Accomplished in specialised standards development skills (data analysis & reporting standards (SDTM, ADaM)) or accomplished experience in Biometrics functions (eg, Programming)Knowledge of MS Excel, deep attention to the details and a systematic approach to workGood knowledge of the clinical development processGood Project management skillsGood knowledge of industry standards (eg, CDASH, SDTM, ADaM)Good communication skills in both written and spoken EnglishA clear demonstration of behaviours of truth seeking rather than success seekingEmbracing peer reviewDesirableAbility to apply clinical data standards technical knowledge to problem solvingAbility to proactively manage concurrent activities within roleUnderstanding of programming languages (eg, SAS, R)Date Posted21-maj-2024

Closing Date28-cze-2024

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