Welwyn Garden City, United Kingdom or Mississauga, Ontario, Canada

 

Data have 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 and Accountabilities:

  • Contribute and/or lead the design, implementation and governance of biomedical (including clinical trial) data standards from protocol to submission including the identification of the needs of key stakeholders and assisting in the prioritization of new biomedical data standards.
  • Contribute to the maintenance of content in the Global Data Standards Repository (GDSR), or future tools, to ensure that it reflects the latest approved biomedical data standards
  • Collaborate with Data Standards representatives from other companies and Standards Development Organizations (SDOs) to ensure proactive adoption of new industry standards and to provide Roche input into their development. Represent Roche externally to SDOs and other organizations involved in the implementation of data standards.
  • Help embed the culture of FAIR data principles and good data stewardship across Biometrics and beyond
  • Develop and maintain a network of key individuals (internal and external) who support the communication and evolution of data standards.

Required Technical Qualifications, Experiences and Competencies:

  • 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
  • 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 and high attention to detail
  • Must possess excellent oral & written communication and technical writing skills in English
  • In-depth understanding of clinical trial lifecycle 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 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
  • Knowledge of a specific therapeutic area or disease area is a plus

Other:

  • Global position – will require regular interactions with colleagues at all sites
  • Travel will be required – at least 2 international trips per year

For More Information and To Apply