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Director, Statistical Programming (Remote)

Company: Jazz Pharmaceuticals
Location: Sharon Hill
Posted on: June 8, 2024

Job Description:

If you are a Jazz employee please apply via the Internal Career siteJazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and follow @JazzPharma on Twitter. Brief Description: The Director will be responsible for managing the product leaders and external FSP personnel, overseeing all ongoing clinical studies, and planning the operational aspects of all new clinical studies.The Director will support Integrated Data Analytics and Statistical Programming in statistical analysis and oversee statistical programming activities for all clinical studies. The Director will also maintain the programming process and ensure compliance with SOPs (Standard Operating Procedures) to produce quality and timely deliverables. In addition, the Director will use their strong people management skills to provide direct line management to regular and contract statistical programmers. -Essential Functions

  • Oversee Clinical Analysis Reporting Leads for delivery and execution based on planned timeline and strategic goals.
  • Critically review programming strategy and timelines and impact on the clinical trials.
  • Partner with Clinical Analysis Reporting Leads, respect their responsibilities, and constantly seek diverse perspectives. Encourage them to take educated risks and find new ways to solve problems.
  • Collaborate with Biostatistics [clinical and medical affairs], data science, regulatory, clinical development, medical writing, and other vital functions and represent Statistical programming as the strategic partner to deliver the following but not limited to:
    • A partner who is the advisor for the functional teams and represents the Statistical Programming
    • Deliver the cross-functional process improvement projects as the single point of contact and or ensure within the Process improvement framework that they are completed
    • Ensure adoption of the new technologies, the process developed with the Statistical Programming are adopted by the teams in the other departments
    • Be the point of escalation and or contact remove any obstacles and or barriers for the Clinical Analysis Reporting Leads
    • Work collaboratively with multiple product leads and manage strategic priorities and resources. - Make recommendations based on the workload for hiring FTE and FSP to the leadership team. -
    • Work closely with management and finance partners to manage and maintain the statistical programming budget for FSP.
    • Perform programming and QC for statistical programming deliverables as needed.
    • Develop statistical programming performance requirements and measurements according to the Jazz standards. Perform ongoing assessment/measurement of team performance against set standards.
    • Perform semi-annual and annual performance reviews and development plans for reports.
    • Maintain a positive, results-orientated work environment, modeling teamwork and communicating to the team in an open, balanced, and objective manner.
    • Qualifications:
      • Bachelor or Master's Degree in Statistics, Mathematics, or related fields; A Master's degree is preferred -
      • 15+ years of statistical programming experience in the Pharmaceutical/Biotech Industry
      • Demonstrated strong leadership qualifications, including strategic thinking, contingency planning, problem-solving, and dispute-resolution skills
      • Ability to execute and manage multiple simultaneous projects and deadlines with shifting priorities and resources in a fast-paced working environment
      • Clear and effective verbal and written communications across disciplines in the company
      • Extensive experience managing CROs or FSPs to scale up or down as the workload permits
      • Good knowledge of drug development regulations pertinent to statistical analysis
      • Solid experience with global clinical trial practices, procedures, and methodologies
      • Thorough understanding of clinical trial design and reporting process, as well as regulatory reporting requirements, including electronic data submissions and CDISC implementation
      • Excellent SAS programming skills and willingness to lead the implementation of new software (i.e., R, Python)
      • Must be highly motivated and able to work well under pressure and shift priorities independently as a team leader and as a team member
      • Must be willing and able to write and validate SAS code (study-level programming support) if necessary
        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.
        FOR US-BASED CANDIDATES ONLYJazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive.
        For this role, the full and complete base pay range is $192,000-$288,000. Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis.
        At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan.
        The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here:

Keywords: Jazz Pharmaceuticals, Philadelphia , Director, Statistical Programming (Remote), Accounting, Auditing , Sharon Hill, Pennsylvania

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