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Senior Standards Developer - Analysis & Reporting Standards

Ort Warschau, Woiwodschaft Masowien, Polen Bengaluru, State of Karnataka, Indien Anzeigen-ID R-194841 Veröffentlichungsdatum 12/07/2024

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 Accountabilities

  • Develops and maintains median/high complexity analysis and reporting standards (SDTM, ADaM)
  • Monitor and updates requests for A&R Standards updates 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  the other team members in the 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 

Education, Qualifications, Skills and Experience

Essential

  • BSc 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 work
  • Good knowledge of the clinical development process
  • Good Project management skills
  • Good knowledge of industry standards (eg, CDASH, SDTM, ADaM)
  • Good communication skills in both written and spoken English
  • A clear demonstration of behaviours of truth seeking rather than success seeking
  • Embracing peer review

Desirable

  • 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)


10001262 D CDDM

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