Senior or Principal Biostatistician

United Kingdom
21 Jun 2021
21 Jul 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Principal Biostatistician

Permanent Role

Homebased Flexibility

Jonathan Cunliffe at Umbilical Life is shortlisting for a Principal Biostatistician to join an established Pharmaceutical based in Germany.

I would like to speak to experienced Statisticians looking to gain more experience across the entire development programme in various therapy areas and Oncology being one.

Accountable for:

  • Provide statistical input to the design, analysis, reporting and interpretation global development programs. 
  • 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.
  • Defending the statistical approach at regulatory agencies such as EMA, FDA, PMDA.
  • 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.
  • 6+ years clinical trial statistics experience in Pharma or CRO environment.
  • 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).
  • Knowledge of statistical software SAS or R
  • Special knowledge in multiple testing procedures, time-to-event methods, adaptive clinical trials and pharmacometrics
  • Knowledge of industry standards, such as the ICH guidelines, CDISC standards/implementation guides, 21 CFR Part 11, and FDA guidelines.

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