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  • Posted: Aug 11, 2021
    Deadline: Not specified
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  • Cytel Inc., an advanced analytics leader with over thirty years of experience providing sophisticated quantitative insights to executive decision-makers in the lifesciences. Cytel employs a range of data science tools from biostatistics to machine learning to help executives in the life-sciences to make confident decisions powered by data. We are probably...
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    Senior/Principal Biostatistician - Neuroscience FSP (Remote)

    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

     

    What’s in it for you:

    • You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development
    • You will be part of an exciting new chapter in Cytel’s 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

    Method of Application

    Interested and qualified? Go to Cytel on careers.cytel.com to apply

    Note: Never pay for any training, certificate, assessment, or testing to the recruiter.

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