Senior Biostatistician Neuroscience - FSP

Senior Biostatistician Neuroscience - FSP

Cytel

Switzerland

As Senior Biostatistician, adapt at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies, with a focus on Neurological Disorders.

You will contribute by:

  • 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.

What we’re looking for:

  • Master’s degree in statistics or a related discipline. PhD strongly desired;
  • 3+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired;
  • 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;
  • Experience working with cross-functional teams, a Study Management Team (SMT) or similar teams for different clients;
  • Effective communicator: able to explain methodology and consequences of decisions in lay terms;
  • Team player; willingness to go the extra distance to get results, meet deadlines, etc.;
  • Ability to be flexible when priorities change and deal with ambiguity.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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