Jazz Pharmaceuticals

  • Associate Director, Biostatistics – Global Biostatistics Liaison

    Job Locations US-PA-Philadelphia | US-PA-Philadelphia
    Posted Date 5 months ago(6/29/2018 5:57 PM)
    Job ID
    # of Openings
    Research & Development
  • Overview

    Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

    Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

    We are looking for the best and brightest talent to join our team.  If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals. 

    Position Profile

    Brief Description:

    The Associate Director, Biostatistics –  Global Biostatistics Liaison will be functioning as a lead on Jazz Pharmaceuticals clinical development projects for biostatistics related organization of Data Monitoring Committees (DMC) or Data Safety Monitoring Boards (DSMB), will provide statistical support for annual IND updates, PSUR/DSUR, will serve as the main contact and relationship manager for biostatistics department strategic partners and vendors, and provide statistical methodological and oversight/verification support to health economics and outcomes research (HEOR) as needed.  This position will work collaboratively with biostatisticians, statistical programmers, clinicians, data managers, strategic outsourcing personnel, safety/pharmacovigilance representatives, medical writers, HEOR representatives and outside vendors across therapeutic areas of Jazz clinical development programs.

    Essential Functions

    • Manage timely and efficient organization of DMC/DSMB including charter development, member identification, meeting organization, data content specification, and overall communication with the DMC/DSMB and/or the independent statistical center supporting the DMC/DSMB
    • Establish efficient process and achieve cross functional alignment for definition and generation of analyses addressing annual IND/safety/regulatory updates. Serve as the primary coordinator within biostatistics function to define the content and timeline for the necessary statistical outputs for annual IND updates and PSUR/DSUR.   Support lead molecule statisticians in generation and verification of biostatistics deliverables.
    • Assist study statisticians and statistical programmers in managing CROs regarding statistical activities and providing guidelines and standards to CROs to ensure quality of deliverables
    • Serve as the biostatistics representative in strategic partner discussions, vendor issue escalations and CRO proposal evaluations.
    • Work with department head, biostatistics and statistical programming leadership as well as all members of the department to develop, implement, and maintain department standards and practices
    • Conduct independent research and propose approaches for implementation of interim analyses logistics and decision making bodies that are aligned with available regulatory guidances
    • Develop statistical programs as necessary to perform analysis, prepare data displays, verify data accuracy and validity
    • Support Health Economics and Outcomes research as well as other internal groups within Medical Affairs or Clinical development in overseeing/running independent analyses.

    Minimum Requirements

    • Master's Degree in Statistics, Biostatistics, Public Health, or related fields
    • A minimum of 8 years of experience is required  
    • Familiarity with Data Monitoring Committees and related regulatory guidances
    • Experience working with/at a CRO is preferred
    • Knowledge of clinical trial design and understanding of statistical applications for clinical trials
    • Good knowledge of drug development regulations pertinent to statistical analysis
    • SAS programming skills and an understanding of CDISC models and standards
    • Excellent writing and communication skills, demonstrated leadership abilities and excellent interpersonal skills

    Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.


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