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    Principal Biostatistician - United Kingdom - Cytel - EMEA

    Cytel - EMEA
    Cytel - EMEA United Kingdom

    1 week ago

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    Description

    At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful.

    A Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies.

    Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation.

    As a Senior Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.

    Our Senior Biostatisticians perform ad-hoc or exploratory analyses to support submission or Health Authority Questions.

    Having exposure to regulatory work experience is a bonus, for example, if you understand the regulatory questions and translating them to statistical problems, collaborating effectively, with clinical and regulatory colleagues.

    Supporting medium complexity clinical trials (starting from Design to Archival experience) and supporting some project-level activities.
    Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications
    Performing statistical analyses and interpreting statistical results
    Master's degree in statistics or a related discipline. 8+ 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.
    ~ Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers. Solid understanding & implementation of CDISC requirements for regulatory submissions.
    ~ Adept in ADaM specifications generation and QC of datasets
    ~

    Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally.

    With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

    At Cytel, our focus is to provide you with a comprehensive and competitive total reward package.

    In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

    We believe in applying scientific rigor to reveal the full promise inherent in data.
    We believe in collaboration and invite a diversity of perspectives, drawing on a variety of talents to create a wealth of possibilities
    Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
    Generating complex ad-hoc reports utilizing raw data
    Applying strong understanding/experience of Efficacy analysis
    Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
    Being adaptable and flexible when priorities change

    Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, etc.

    At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent.

    At least 6 years of related experience with a master's degree or above.
    Study lead experience, preferably juggling multiple projects simultaneously preferred.
    Strong SAS data manipulation, analysis and reporting skills.
    Strong QC / validation skills.
    Good ad-hoc reporting skills.
    Proficiency in Efficacy analysis.
    Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.
    xml and other submission documents.
    Ability to provide quality output and deliverables, in adherence with challenging timelines.

    Cytel is a Global CRO providing ground-breaking biostatistical software and services to large pharma and emerging Biotech clients globally.

    With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

    At Cytel, our focus is to provide you with a comprehensive and competitive total reward package.

    In addition, our world class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.


    Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.



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