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 through release. Adherence to global data standards & 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 Biomedical Data Standards Specialist - Controlled Terminology Specialist supports this effort by contributing to the design, implementation and governance of biomedical data standards (in particular those responsible for controlled terminology) from protocol to submission and beyond by being a technical, process and business expert on industry wide biomedical data standards, in particular, controlled terminology. They maintain content in a metadata repository to ensure it continuously reflects the latest approved biomedical data standards.
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
- Develops and maintains network of key individuals (internal and external) who support the communication and evolution of data standards.
Required Technical Qualifications, Experiences and Competencies
- BSc or MSc in biochemistry, bioinformatics, biomedical/health science or similar areas of academic discipline OR practical experience of clinical trial design, analysis and reporting
- Experience and an in-depth understanding of CDISC Controlled Terminology
- Ability 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.
- Ability to support, coach and motivate other members of the team and other functions (could be locally or at other sites)
- Good communication skills – written and oral. Confident in communicating to all levels of the organisation and across organisational boundaries
- Drive for Results (Demonstrates interest and ability to learn new things, takes initiative, welcomes problems as challenges; finds solutions to technical problems)
- Global position – will require regular interactions with colleagues at all sites
- Travel will be required – at least 2 international trips per year.
Who We Are
Our UK Pharmaceutical head office is situated in Welwyn garden City, Hertfordshire, with beautiful country side surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. With over 1400 people occupying our site in Welwyn, you can expect opportunities in Early Development (pRED), Product Development (PD), Commercial (Rx) and of course our corporate function.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Location Welwyn, UK