• Biostatistician II-III, SCHARP

    Job ID
    14385
    Type
    Regular Full-Time
    Company
    Fred Hutchinson Cancer Research Center
    Location
    US-WA-Seattle
    Category
    Biostatistics, Bioinformatics and Computational Biology
  • Overview

    Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

     

    The Statistical Center for HIV/AIDS Research and Prevention (SCHARP) at Fred Hutch is a full service statistical and data management center focused on HIV prevention research. SCHARP has an annual budget of over $40 million, more than 180 employees and is currently managing over 40 active phase I – III clinical trials in over 150 clinical sites around the world. SCHARP is seeking a Statistical Research Associate (SRA) who will provide statistical support, which may include reviewing protocol drafts, participation on the protocol development team, and assisting the protocol lead statistician in the design of appropriate analyses. The SRA will write statistical analysis plans for protocols and complete the analysis.

    Responsibilities

    The incumbent works independently designing, developing, coordinating and performing statistical aspects of study design, implementation, and analyses for clinical trials. The incumbent serves as lead on more than one protocol and may provide mentorship to at least one other SRA. The incumbent works well under pressure, has established a positive and productive working relationship with faculty statisticians and/or industry partners and exercises good judgment with defined practices and policies. Technical skills are strong and reliable, and productivity is high demonstrated by attention to detail, compliance with regulations and best practices, and adherence to deadlines.  


    Responsibilities may include some or all of the following:  

     

    • Provide statistical analyses in the form of tables, listings, and figures and/or written summaries of study data and results for use in reports, for example, Data and Safety Monitoring Board meetings, scientific papers, or tables in support of a Clinical Study Report for submission. 
    • Review protocol drafts .
    • Participate in describing and defining statistical considerations in study protocols (ex: sample size/power/analysis models) .
    • Participate in the development of statistical analysis plans. 
    • Participate in the development of quality assurance procedures for on-going data collection and analysis, such as establishing edit checks, or HIV endpoint verification. 
    • Participate in the development and verification of randomization lists.
    • Provide input into the development of case report forms. 
    • Collaborate with programmers in production and verification of standard reports. 
    • Coordinate production of statistical reports in accordance with CDISC data standards and guidelines.
    • Assist in the production of supporting CDISC documentation for submissions (Define.xml, Reviewer’s Guides).
    • Participate in protocol team conference calls and meetings. 
    • Provide statistical consultation for research projects. 
    • Archive statistical files and documents. 
    • Evaluate new statistical software packages. 
    • Represent statistical unit at study organizational meetings.  
    • Represent study at scientific meetings.  
    • Give oral presentations of study results.  
    • Assist other statistical research associates with statistical analyses. 
    • Collaborate with internal PhD statisticians/epidemiologists and external subject-matter experts to perform statistical analyses of clinical trials data for production of abstracts and manuscripts. 
    • Perform other responsibilities as required. 

    Qualifications

    Required:

    • A master's degree in Statistics or Biostatistics or related field.
    • A minimum of three years of experience working in clinical trials.
    • Proficiency in statisitcal computing including SAS and R.
    • Excellent oral and written communication skills.
    • Ability to effectively collaborate with internal and external colleagues in a team environment.

    Preferred:

    • Proficiency in programming statistical reports using CDISC data standards.
    • Experience in producing statistical reports in suport of an FDA submission.

     

    Our Commitment to Diversity

    We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at escmail@fredhutch.org or by calling 206-667-4700.

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