Roche

Global Data Standards Manager

Company
Roche
Location
Welwyn
Salary
Competitive
Posted
17 Jun 2019
Closes
17 Jul 2019
Ref
201903-108184
Discipline
R & D
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Title: Global Data Standards Manager
Division: Product Development
Location: Welwyn or Mississauga

Responsibilities:
  • Contribute to the design, management and maintenance of biomedical (including clinical trial) data standards from protocol development to regulatory submission
    • Help to identify the needs of key stakeholders and assist in the prioritization of new clinical data standards for inclusion in the Data Standards & Governance (DSG) Roadmap
    • Lead the development of new biomedical data standards from protocol development to regulatory submission
    • Support the technical implementation and adoption of biomedical data standards
  • Active role in the governance of biomedical data standards
  • Contribute to the curation and integration of data for the creation of data marts:
    • Provide guidance to key stakeholders relating to transforming previously collected biomedical data to the appropriate data models
  • Help to maintain content in the Global Data Standards Repository (GDSR)
  • Develop and deploy metrics that assess the usage and value of the biomedical data standards
  • Drive adoption of biomedical data standards from external standards development organizations (SDOs) such as CDISC, HL7, ISO:
    • Actively monitor and assess standards being produced by SDOs
    • Serve as a member of the SDOs
    • Actively promote and leverage knowledge sharing with standards experts within Product Development, more broadly across the Roche group and the industry as a whole
  • Identify and propose improvements to processes related to biomedical data standards design, management, maintenance and implementation
  • Provide DSG updates in local forums (e.g., PDB All Hands, Lunch and Learn sessions, local functional meetings)


Qualifications:
  • BS/BA or MS in computer science, mathematics, statistics, or related areas of Clinical Research
  • Experience in pharmaceutical industry, including standards development or implementation within a Biometrics field
  • Experience with CDISC ADaM and other industry standards, possibly including CDISC CDASH, SDTM and/or Controlled Terminology
  • Previous experience as a Study Statistician or Statistical Programmer is a plus
  • Knowledge of a specific therapeutic area or disease area is a plus
  • Able to work independently and with other team members cross-functionally to perform impact analyses as part of a change management process, and/or provide support for the implementation of technical projects
  • Must have advanced process-related analytical skills
  • Outstanding organizational skills
  • High attention to detail
  • Must possess excellent oral & written communication and technical writing skills in English
  • Strong presentation skills required
  • In-depth understanding of clinical trial life cycle processes required, including but not limited to Protocol Design, Clinical Data Management, Statistical Programming, Statistical Analysis and Electronic Submissions (eSUB)
  • In-depth working knowledge of ADaM
  • In-depth working knowledge of Statistical Analysis Plan components
  • Proven experience of defining data analysis concepts  
  • Proven experience of translating statistical analysis requirements into technical specifications
  • In-depth understanding of data collection design vis-à-vis statistical analysis requirements
  • Good understanding of SDTM
  • Good understanding of controlled terminology

Roche is an equal opportunity employer.
Research & Development, Research & Development > Biometrics

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