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Senior/Principal Biostatistician - Biosimilars

Company: PAREXEL
Location: Lehigh Acres
Posted on: August 28, 2020

Job Description:

As an experienced Biostatistician, you will lead research design and analytical strategies, provide input into protocols, develop and review statistical analysis plans and author/co-author reports, abstracts and manuscripts. You will use your expertise to advise, provide guidance and to oversee the quality control of statistical deliverables. As the functional lead within a study team, you will lead the Biostatistical activities on a study and be accountable for the deliverables. Senior and Principal level Biostatistician at Parexel are client-facing and play an integral part in the study team.

Our Biostatistics teams are not only focused on delivering quality results for our clients needs, but also value working with one another in a flexible environment. Although some team members are home-based and others are office-based, our virtual resources support our teams to work collaboratively and effectively across the globe.

Around 30% of our Biostatistics team have been a part of the Parexel family for a minimum of 5 years. Our team is made up of experienced and highly educated professionals in our field. This is truly a statistic that speaks for itself!

Please note: this position requires non-interventional study/ real world evidence experience

In this role you may:

Supervise, advise and review:


  • Supervise complex statistical analyses and provide input to statistical reports.
  • Develop complex analysis strategies and execute them using efficient programming techniques (software: SAS, R)
  • Provide expert input to analysis plans, statistical reports, statistical sections of integrated clinical reports
  • Be a pro-active advisor for all types of analysis during the proposal process as well as during the project life cycle
  • Review analysis data sets and quality control all types of statistical analysis deliverables


    Lead and cooperate:


    • Cooperate with other biostatistical and company departments to optimize global efficiency
    • Coordinate Biostatistics related project activities for successful completion within given timelines and budget
    • Interact with clients with regard to data analysis, scope of work, and budget.
    • Represent Parexel at client meetings
    • Train/mentor junior members of the department


      QualificationsEducation:


      • PhD or Masters (with sufficient work experience) in a statistical discipline required


        Experience:


        • Specific experience in equivalence or non-inferiority clinical trials and PK/PD/Immunogenicity analyses required
        • Preferred: experience in biosimilar application and familiarity with concept of extrapolation
        • A thorough understanding of the statistical aspects of either clinical trials and/or observational research
        • Industry experience required (CRO/Pharma)
        • Familiarity with noninterventional studies and/or real world evidence
        • Experience in statistical analysis in a clinically related subject, either within clinical trials or in Epidemiology
        • SAS programming skills required


          Skills:


          • Confident, self-reliant and a quick learner who enjoys working in a matrix team
          • Good leadership skills
          • Strong oral and written English communication skills
          • Ability to travel as required, although this is not frequent
          • Work ethically and honestly to promote the development of life changing treatments for patients


            EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Keywords: PAREXEL, Lehigh Acres , Senior/Principal Biostatistician - Biosimilars, Other , Lehigh Acres, Florida

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