Senior or Principal Biostatistician

Location
United Kingdom
Salary
Competitive
Posted
10 May 2021
Closes
09 Jun 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Senior or Principal Biostatistician

Permanent Role, Remote in Europe

Jonathan Cunliffe at Umbilical Life has partnered with an established global CRO looking to build up their presence in Europe within their new Biometrics group.

I would like to speak to experienced Statisticians who wish to join this organisation in their exciting period of growth. For a confidential conversation call Jonathan Cunliffe on +49 3221 421 9777.

Accountable for:

  • Provide statistical input to the design, analysis, reporting and interpretation of clinical trials.
  • Preparing regulatory submission documents.
  • Leading the activities of all statistical deliverables.
  • Manage project budgets, support financial reporting for studies, identify of out of scope work.
  • Provide biometrics leadership and coordination across client and other vendor functional areas, including clinical operations, data management, regulatory, and medical teams
  • Identify project priorities and project timeline goals and communicate priority-related issues and timelines to programming and support teams

Qualifications/ Requirements:

  • Masters or PhD in a statistical field.
  • 4 year's experience within clinical trials.
  • Lead experience of both people and projects.
  • Good knowledge of statistical design, analysis and regulatory requirements relating to clinical development.
  • Expertise in designing clinical trials, including the development of study related documents (e.g. Statistical Analysis Plan, Statistical part of Study Protocols, Case Report Form, Data Management Plan, IDMC Charter).
  • Knowledge of statistical software SAS or R
  • Knowledge of industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.

*Candidates will need to have right to within the EU.

 

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