Advanced Group

  • Principal Biostatistician

    Job Locations US-Nationwide
    Req No.
    2018-9749
    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.

     

    A Principal Biostatistician is responsible for independently planning and managing project deliverables and study-level analysis and reporting activities and for providing statistical support for clinical trials.

    Responsibilities

    Statistical Responsibilities:

    • Apply knowledge of statistics, statistical programming, and pharmaceutical regulations to drug development projects
    • Participate in the design and review of clinical protocols, including preparation of statistical sections, sample size calculations, randomization, and study design
    • Prepare and review statistical analysis plans (including shell tables, listings, and figures) 
    • Prepare and review programming specifications used in creating derived datasets, tables, listings, and figures
    • Perform efficacy and safety analyses for clinical trials data and participate in validation and quality checks for statistical output
    • Implement and support CDISC (both SDTM and ADaM) and other regulatory standards
    • Review CRFs, database specifications, and database validation checks

    Project Management Responsibilities: 

    • Plan and manage project- and study-level analysis and reporting activities
    • Communicate with clients and colleagues on statistical issues and project status 

    Standard Operating Procedures (SOPs): 

    • Be familiar with and follow departments Standard Operating Procedures (SOPs)
    • Assist in creating, revising and review of department SOPs

    Business Development: 

    • Assist in preparing monthly revenue reports for biostatistics
    • Assist with RFP/RFI completion and attend sales meetings as requested by Business Development 

    Additional Responsibilities; 

    • Performs other duties as requested by management 

    Qualifications

    The ideal candidate should have an advanced degree (MS or PhD) in Statistics or a closely related field, with a minimum of 5 (PhD) or 7 (MS) years of experience in pharmaceutical development and SAS programming for statistical analysis. Candidate must have experience in clinical trial design and must comply with regulatory requirements. Excellent oral and written communication skills, organizational skills, and attention to detail are required. 

     

    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:

    Our Culture: https://careers.advancedgroup.com/embrace-our-culture

    Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential

    Community Programs: https://careers.advancedgroup.com/unleash-your-passion

    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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