Data 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 Biomedical Data Standards Specialist supports this effort by driving 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. They maintain content in a metadata repository to ensure it continuously reflects the latest approved biomedical data standards. The present position focuses on eCRF data collection standards including controlled terminology.
Responsibilities and Accountabilities
- Develop long term strategy for the design, implementation, governance and use of biomedical data standards in line with Roche Pharma objectives.
- Lead and contribute to the design, and governance of biomedical (including clinical trial) data standards from protocol to submission including the identification of the needs of key stakeholders for all studies in PD, pRED, and gRED.
- Lead and contribute to the implementation into tools (e.g. RAVE, SAS and R) of the biomedical (including clinical trial) data standards from protocol to submission for use by molecule and study teams.
- Guide the strategy for the prioritization of the development of new biomedical data standards.
- Lead and contribute to specialist teams within the Pharma Data Governance framework or other future governance models
- Extensive expert knowledge and understanding of biomedical data standards and the programming tools (e.g. RAVE, SAS, R) available for their implementation. Ensures the biomedical data standards continue to meet the needs of Roche Pharma.
- Lead and contribute to the GDS Request process with the goal of continually growing the biomedical data standards. Evaluate requests for topics including, but not limited to impact analysis, risk assessment, cost/benefit analysis, proposal of alternatives.
- Provide specialist advice and support the implementation of biomedical data standards to all of Biometrics (Biostats, SPA, CDM and PCOR) on molecules across PD, pRED and gRED and the transformation of previously collected data to the appropriate data models supporting data curation across PD, pRED and gRED.
- Contribute to the maintanence of content in the Global Data Standards Repository (GDSR), or future tools, to ensure that it reflects the lastest approved biomedical data standards
- Provide input to MDIS Information Architects in the design of biomedical data models and implementation data models.
- 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.
- Drive a culture based on FAIR data principles and good data stewardship across Biometrics and beyond
- Continuous improvement: Reviews the process, deliverables and feedback to identify potential areas requiring adjustment or review and ensures quality deliverables.
- Ensures appropriate project planning and maintains good record keeping of activities. Generates metrics regarding the performance of processes (including key performance indicators or KPIs) and the usage and value of biomedical data standards.
- Develops and maintains a network of key individuals (internal and external) who support the communication and evolution of data standards. Uses a variety of communication channels to raise awareness (PDConnect, “how to” documents, presentations etc.)
- Other responsibilities as delegated
Required Technical Qualifications, Experiences and Competencies
- BSc or MSc in computer science, mathematics, statistics, biochemistry, bioinformatics, biomedical/health science or similar areas of academic discipline OR BSc or MSc in an alternative subject with practical experience in clinical trial design, analysis and reporting
- Pharmaceutical industry experience with knowledge of clinical trial conduct and reporting OR in applying and managing healthcare data in Industry, Academia or Research settings
- Experience and understanding of CDISC Controlled Terminology
- Experience and an in-depth understanding of industry biomedical data standards, including at least one of CDISC CDASH, CDISC SDTM and CDISC ADaM
- Experience in implementing biomedical data standards within a Biometrics function using programming tools (e.g. RAVE, SAS, R)
- An understanding of clinical trial lifecycle processes required, including but not limited to Protocol Design, Clinical Data Management, Statistical Programming/Biostatistics and Electronic Submissions (eSUB) Processes
- 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
- High level knowledge and understanding of semantic technology and linked data is a plus
- Good knowledge of English in a business environment
- Knowledge of functions and processes within Roche involved in drug development is a plus
- Understanding of Product Development Biometrics processes and roles of Product Development Biometrics as related to data delivery, analysis and reporting
- Ability to support, coach and motivate other members of the team and other functions (could be locally or at other sites)
- Systematic and structured approach to tasks. Able to deal positively with multiple requests and priorities. Analytical. Good attention to detail
- 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)
- Critical thinking skills
- Able to represent Roche in external forums, e.g. communicating with requesters, at industry meetings
- Diplomatic and collaborative in approach. Willing to challenge and generate debate in a constructive manner
- Able to make decisions and be proactive
- Deals positively with ambiguity
- Builds networks beyond PDB to further develop support and tools for the organisation
- Knowledge of a specific therapeutic area or disease area is a plus
- Global position – will require regular interactions with colleagues at all sites
- Travel will be required – at least 2 international trips per year