Data Standards Subject Matter Expert

Posted 5 February by AstraZeneca Featured

Position:           Data Standards Subject Matter Expert (SME).

Location:          Cambridge, UK.

Package:           Competitive with excellent benefits.

At AstraZeneca, we have created and strategically acquired one of the most enviable Oncology pipelines in the pharmaceutical industry.  In addition to developing this pipeline using in-house capabilities, we also partner with a host of biotech companies to leverage new, disruptive technologies. 

We have an exciting new opportunity for a CDISC data standards Subject Matter Expert (SME) in a highly visible role, interacting with a wide range of internal and external stakeholders. You will provide technical expertise in the development of processes, initiatives and management of SEND data, in order to allow the Non-clinical submissions team to deliver on FDA regulatory requirements for nonclinical data standards, and to maximise the opportunities this presents for Industry.

In addition to the above, you will have responsibility for:

  • Providing support across nonclinical functional areas to promote and enforce the use of non-clinical data standards. Maintaining metadata libraries, as adapted from industry standards.
  • Reviewing and assessing the impact of newly released and updated data standards and incorporate into AZ business practices, as applicable.
  • Communicating AZ data requirements to external vendors. Interacting with external vendor personnel regarding standardized data transfer specifications, as necessary.
  • Assuming responsibility for quality validation and management of non-clinical datasets.Providing training to internal customers as appropriate.

    REQUIREMENTS:

    Education: 

    Bachelor’s degree (B.A./B.S.) or equivalent in a scientific or related discipline.

    Knowledge and Experience

    • Significant related experience in a scientific environment. An equivalent combination of education and experience may be accepted in substitute for the specific education and experience given above.
  • Knowledge of CDISC standards is essential.
  • Understanding of non-clinical study designs, data and documentation (e.g. plan/protocol, study schedules, deviations, drafts and final reports).Knowledge of regulatory guidelines and industry standards (FDA, ICH/GLP, PhUSE).

    If you are interested, apply now!

    AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

  • Reference: 34399065

    Bank or payment details should not be provided when applying for a job. reed.co.uk is not responsible for any external website content. All applications should be made via the 'Apply now' button.

    Report this job