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Senior or Principal Biostatistician

Employer
Umbilical Life
Location
United Kingdom
Salary
Competitive
Start date
21 Jun 2021
Closing date
21 Jul 2021

Job Details

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.

Company

Umbilical will be a world leading provider of workforce solutions in Science, Technology and Engineering. 

Blending innovation and a commitment to entrepreneurship, we will ensure our customers and colleagues achieve the highest levels of satisfaction.

With nearly 75 years of workforce industry experience between us we know a lot, but not everything. 

We have created a Mission, Vision and a set of clear Values, providing‘guiding light’ as we all start building this Culture, or as we call it the CODE.   

 

Company info
Website
Telephone
011 6 461 0070
Location
Premier House
9 Rutland Street
Leicester
LE1 1RE
United Kingdom

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