Principal Standards Developer

  • Salary: 50,000 - 60,000
  • REF Number: 00034612
  • Consultant: Stephanie Maccioni
  • Contact: 01438 743047
  • Date Published: 08.12.2015
  • Closed Date: 14.03.2016
  • Sector:
  • Location: Cambridge,
  • Discipline:

Stephanie Maccioni at CK Clinical is looking for a Principal Standards Developer for permanent employment with a Global Pharmaceutical company for office based work in Cambridge.

Main duties and responsibilities:

  • Develops and maintains Clinical Data Standards at the Corporate level including Raw Data, SDTM, RDB/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)
  • As a key member, participates on TA Standards Definition Team(s)

Key Requirements:

  • BSc or MSc in computer science, mathematics, statistics or life sciences
  • Excellent communication and collaboration skills - experience in working in across global and functional boundaries
  • Ability to apply expertise to problems, problem solving and quality focus
  • Extensive SAS programming expertise at an advanced level
  • Extensive experience of clinical project data base development and reporting
  • Knowledge of technical and regulatory requirements related to the role
  • Excellent knowledge of CDASH/SDTM/ADaM CDISC Standards and the end to end alignment of Clinical Data Standards and their use in drug project
  • Experience in authoring of Procedural and guidance documents

  • Full job description available upon request#

For more information or to apply for this position, please contact Stephanie Maccioni on 01438 743047 or smaccioni@ckclinical.co.uk. Alternatively, please click on the link below to apply online now.

CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL34612 in all correspondence.

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