Advanced Group

  • Senior Biostatistician

    Job Locations US-Nationwide
    Req No.
    2018-9977
    Type
    Regular Full-Time
    Client
    Advanced Clinical
  • Overview

    Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there’s no better place to grow your career than Advanced Clinical.

     

    Responsibilities

    A Senior Biostatistician is responsible for providing statistical support and SAS programming support for clinical trials. This includes leading a trial, participating in SAP development, preparing and reviewing programming specifications, analyzing data and reviewing case report forms (CRFs), and database structures. 

    • Follow Standard Operating Procedures (SOPs).
    • Assists with creating, revising, and reviewing SOPs as needed
    • Apply knowledge of statistics, statistical programming and pharmaceutical regulations to fulfill primary duties.
    • Prepare statistical analysis plans (including shell tables, listings, and figures).
    • Prepare and review programming specifications used in creating analysis datasets, tables, listings, and figures.
    • Perform efficacy and safety analyses for clinical trials data and participate in validation and quality control of statistical output.
    • Contribute to the development and improvement of standards for statistical activities.
    • Work closely with data management and database teams in the development of CRFs, database specifications, and database validation checks.
    • Implement and support CDISC (both SDTM and ADaM) and other regulatory standards.
    • Perform other duties as requested by management

    Qualifications

    • Experience: 2 to 4 years of experience in analyzing clinical trials data, including a minimum of 1 year of that experience in a pharmaceutical or CRO setting.
      • Also must have knowledge of basic statistical concepts, must have strong SAS programming skills, including data manipulation and statistical analysis procedures, and must have experience with Word, Excel, and PowerPoint.
      Education: PhD or Master’s degree in Statistics or a closely related field
    • Training: The below list includes the general training subject, and not necessarily the exact name of the training course obtained.
      • Applicable Standard Operating Procedures
      • Good Clinical Practices (21 CFR; Guidance Documents including ICH Guidelines)
      • Drug Development and Approval Process

    This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).

     

    What’s in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work. Visit the links below to discover all that Advanced Group has to offer:

     

     

    For a complete list of all of our job openings, please visit Advanced Group’s career site here.

     

    It is Advanced Group’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.


    This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job.  If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

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