(Principal / Senior) or Biomedical Data Standards Specialist - Data Analysis

Roche - San Francisco, CA (7 months ago)

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Title: Biomedical Data Standards Specialist.
Division: Product Development
Location: Welwyn or Mississauga

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 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-à-vis statistical analysis requirements
Good understanding of SDTM
Good understanding of controlled terminology
Who we are
Our UK Pharmaceutical head office is situated in Welwyn Garden City, Hertfordshire, with beautiful countryside surrounding the area. Supported by major motorways & airports as well as being a 30 minute train ride to London, access is easy. Our award-winning office, known as Hexagon Place, was opened in 2005 and provides a modern, flexible working environment with facilities that are second-to-none. Around 2,000 people work at our Welwyn office in Global Early Development (pRED), Global Product Development (PD), Commercial (Rx) and our Corporate functions. Roche offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation. There is a fully equipped gym on-site, a library and information centre, and an active sports and social club. We also have a subsidised staff restaurant providing foods to cater for every taste throughout the day. At the heart of the building is an informal meeting area known as The Street which features a coffee shop, snack machine and cashpoint. A second building on-site, called The Hub, contains modern meeting room and conference facilities. Roche promotes personal well-being and work-life balance. Therefore, flexible working options will be considered for all roles at Roche UK.

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.