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Job Details
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Senior Principal bio-statistician - 100% remote *EU only



Business Type: Pharmaceutical Services
Job Type: Statistic - Biostatistics
Job Level: Experienced (non manager)
Position: Full Time
Location: Belgium
Reference: ST297614/01
Closing Date: 29/09/21
Job Details:

For one of our biggest bio-statistics and research knowledge providers within the life science industry, both in services as in software, we are looking for an experienced bio-statistician. Do you see yourself adapting and utilising advanced statistical methods within complex clinical data? This client of ours provides challenging and interesting projects, a lot of career development opportunities and a healthy work-life balance as it is fully remote.

As Senior Bio-statistician you will support or lead one or more Phase I-IV clinical studies. This within the therapeutic area of Neurological Disorders.

Responsibilities:

  • providing statistical support to clinical studies, with a focus on Neurological Disorders (Multiple Sclerosis, HIV, Alzheimer''s, Strokes, etc.);
  • participating in the development of study protocols, including participation in study design discussions and sample size calculations;
  • reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
  • performing statistical analyses;
  • interpreting statistical results;
  • preparing clinical study reports, including integrated summaries for submissions;
  • leading study activities when called upon;
  • utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
  • serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.;
  • being adaptable and flexible when priorities change

Requirements:

  • Master''s degree in statistics or a related discipline.
  • PhD is a plus
  • 2+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
  • Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
  • Knowledge and implementation of advanced statistical methods.
  • Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
  • Strong knowledge of ICH guidelines.
  • Solid understanding & implementation of CDISC requirement for regulatory submissions.
  • Adept in ADaM specifications generation and QC of datasets.
  • Submissions experience

Benefits:

  • Attractive salary
  • You will have the opportunity to play an integral role helping clients and the industry shape the future of drug development
  • You will be part of an exciting new chapter in the company its history with high growth and opportunities to progress in Senior and Leadership positions within the company
  • Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation
  • Work with and leverage the best and brightest minds in the industry
  • A good work-life balance because it is a full remote job

If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via the web page of NonStop consulting. You can find me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!



Posted: 22/09/2021 | NPJ Ref: 283276
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