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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...
    Read more about this company

     

    Principal Biostatistician - Immunology, Late Phase

    Your Impact

    • Provide statistical input into study protocols, Case Report Forms, and data management plans, DSMBs and write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.

    • eSUB/submission

    • PK analysis and clinical pharmacology

    • Longitudinal data/analysis 

    • Provide statistical output as required for manuscripts and ensures that the results are accurately interpreted in the publications.

    • Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate to meetings with regulatory authorities.

    • When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.

    • Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through her/his expertise and customer orientation.

    • Contribute to the development of sourcing strategy for projects.

    •  Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.

    What You Offer

    • Master's degree in Statistics, Biostatistics or related discipline

    • 5+ experience in statistical or biostatistical analysis supporting clinical trial operations for the pharma/biotech industry

    • Experience in late-phase trials required

    • Experience in immunology: GI and Derm studies required

    • eSUB/submission required

    • Experience with longitudinal data/analysis is preferred

    • Demonstrated team leadership for direct reporting relationships and leadership influence over indirect reporting relationships

    • Working SAS & CDISC knowledge required

    • Knowledge of PK/PD desired

    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.

  • Send your application

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