Global Data Standards Manager

Roche
Welwyn
Competitive
17 Jul 2019
16 Aug 2019
201903-108184
R & D , Bioinformatics
Full Time
Permanent
Experienced (non-manager)
Title: Global Data Standards Manager
Division: Product Development
Location: Welwyn or Mississauga

D ata has the power to answer more than one question and enable multiple discoveries, but only if Findable, Accessible, Interoperable, and Reusable (FAIR). Making the FAIR way the easy way to manage data requires having the right processes and infrastructure in place from data planning to data release. Adherence to global data standards and terminologies is critical, not only to ensure that data are FAIR but also to ensure data will meet global regulatory expectations (e.g., for FDA submission). The Global Data Standards Manager supports this effort by contributing to the design, implementation and governance of biomedical data standards from protocol development to regulatory submission and beyond, by being a technical, process and business expert on industry-wide biomedical data standards. The Analysis Standards Specialist role requires experience with CDISC ADaM.

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-√†-vis statistical analysis requirements
  • Good understanding of SDTM
  • Good understanding of controlled terminology

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