Principal Biostatistician

Salary
Competitive
Posted
20 Dec 2018
Closes
20 Jan 2019
Ref
Jon>PB>UK
Contract Type
Permanent

Principal Biostatistician

Permanent Role

Homebased Flexibility

 

Jonathan Cunliffe at Umbilical Life is shortlisting for a Principal Biostatistician to join a leading Pharmaceutical company.

I would like to speak to talented individuals who wish to be an integral part of an exciting team. For a confidential conversation call Jonathan Cunliffe on +49 3221 421 9777 or email Jonathan@umbilical-life.com.

 

Accountable for:

  • Provide statistical input to the design, analysis, reporting and interpretation of clinical trials.
  • Influencing clinical development plans, regulatory and commercial strategies.
  • Identifying and implementing innovative statistical methodologies.
  • Provide guidelines and standards to CROs to ensure quality of deliverables.
  • Represent Biostatistics in meetings with project teams ensuring adherence to FDA/ICH guidelines, Good Clinical Practices, and regulatory requirements. 

 

Qualifications/ Requirements:

  • Masters or PhD in a statistical field.
  • 5+ years of experience within the Biometrics.
  • Strong lead experience of both people and projects.
  • Comprehensive knowledge of statistical methodology in design, analysis and regulatory requirements relating to clinical development of drugs.
  • 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).
  • Profound knowledge of statistical software SAS.
  • Extensive knowledge of industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.

 

 

For a confidential discussion please contact

Jonathan Cunliffe at Umbilical on

+49 3221 421 9777 or email Jonathan@umbilical-life.com

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