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Senior Biostatistician - Germany - Oferta z Jobs.pl

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Senior Biostatistician - Germany

Nr ref.: /JOBS.pl

  • From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we've continued to improve what we do.

    Our Biostatistics group is expert in randomization methods, data collection instrument design and data cleaning and our experts are proficient in the use of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Models (ADaM) with both paper and electronic CTD submission.

    To strengthen this group we are seeking an experienced Statistician to join our global team. This position is located in Germany and can be office based in Munich or home based for the right candidate

    Core responsibilities:
    • Acts as the lead or back-up statistician for multiple projects with any level of complexity
    • Collaborates in the process of protocol development by choosing an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol.
    • Acts as the primary contact with the sponsor for all biostatistics related activities on assigned projects
    • Participates in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting statistician.
    • Writes and reviews Statistical Analysis Plans (SAPs) based on the protocol, including development of well-presented mock-up displays for tables, listings, and figures.
    • Helps manage clinical trials efficiently by providing accurate and consistent information to both sponsors and Company business/functional units.
    • Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings

    • Academically well qualified: MSc or PhD in Statistics or Medical Statistics
    • Extensive experience in clinical trials and the drug development process preferably within a CRO and/or Pharmaceutical environment
    • Strong project leadership experience
    • Ability to apply knowledge of statistical design, analysis and programming techniques used in clinical trials
    • Strong SAS experience

    Why choose us:
    It takes skill and passion to develop medicines the way we do. Don't worry - if you've got the passion part, we'll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.
    We've got an attitude at INC: "Can do, I own it." Absolutely everyone has ownership of what they do here. And because we're given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too.
    "We were ranked "Top CRO" to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide)."

    What happens next:
    If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.


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