Statistician (Global role) - Hertfordshire
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Zest Scientific is partnered with a leading pharmaceutical organisation and we currently have an opportunity for a talented Statistician to join our client’s global, multi therapeutic group.
If you are a statitistical project lead with some experience of ADaM, then we would be delighted to hear from you.
There is a competitive package including negotiable salary and bonuses.
Responsibilities of the Statistician:
- Contribute to the design, management and maintenance of biomedical (including clinical trial) data standards from protocol development to regulatory submission
- Active role in the governance of biomedical data standards
- Contribute to the curation and integration of data for the creation of data marts
- 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:
- 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)
Who we are looking for:
- 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
- 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 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
- 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