Jazz Pharmaceuticals

  • Senior Manager, Statistical Programming

    Job Locations US-CA-Palo Alto | US-CA-Palo Alto
    Posted Date 3 weeks ago(6/27/2018 7:21 PM)
    Job ID
    2018-3658
    # of Openings
    1
    Category
    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

    Senior Manager, Statistical Programming

    The Clinical Programming Group within the Department of Biostatistics is responsible for developing software for the analysis of clinical study data in accordance with departmental SOPs and guidelines.

    Essential Functions

    • Responsible for all statistical programming activities within a therapeutic project or equivalent
    • Lead, manage, develop and support statistical programming team
    • Manage critical deadlines, demonstrate ability to problem solving, and ensure quality statistical programming deliverables will be completed within designated timeframe
    • Serve as project leader on studies or tasks of greater complexity
    • Attend multidisciplinary team meetings, representing the statistical programming function.
    • Create or review and approve programming plans at study and project level. Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)
    • Provide programming leadership for preparation of datasets and TLGs (NDA/BLA) to FDA, EMA, or other worldwide regulatory agencies
    • Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies
    • Assist statisticians by suggesting algorithms to address novel analysis requests
    • Develop software validation procedures and test plans, as necessary
    • Create and document archives of software, outputs, and analysis files
    • Contribute to the creation and maintenance of department SOPs related to clinical data analysis
    • Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately
    • Oversee work of internal contract programmers and external vendors
    • Provide time and resource estimates for project planning

    Minimum Requirements

    • Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life
    • Sciences or other relevant scientific fields; Master’s Degree preferred
    • Minimum of 10 years of experience in developing software for clinical trials
    • using the SAS system, with 3 or more years of supervising SAS programmers.
    • Skilled in programming with SAS. Knowledge of additional programming
    • languages a plus.
    • Good knowledge of statistics and drug development process
    • Experience as a lead programmer for NDAs/BLAs
    • Experience overseeing the work of internal contractors and external
    • vendors (CROs)
    • Experience in pharmacokinetics/pharmacodynamics modeling a plus
    • Good knowledge with CDISC standards, including SDTM and ADaM
    • models
    • Solid verbal and written communication skills

    Description of Physical Demands

    • Occasional mobility within office environment
    • Routinely sitting for extended periods of time
    • Constantly operating a computer, printer, telephone and other similar office machinery

    Description of Work Environment

    • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes
    • Frequent computer use at workstation
    • May move from one work location to another occasionally
    • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands
    • Occasional public contact requiring appropriate business apparel

    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.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Connect With Us!

    Coming Soon!!