Statistician (Global role) - Hertfordshire

Statistician (Global role) - HertfordshireHertfordshireReference: 3151
  • Global Pharmaceutical organisation
  • Excellent package including bonus
  • Some remote working (40-50%)
  • Permanent contract

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

Contact: Neil Dewsbury
Email: neil.dewsbury@zestbusinessgroup.com
Telephone: 0114 238 1728