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Location

Cambridge, MA | United States

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Job description

Job Description

If you are a Jazz employee please apply via the Internal Career site

Jazz 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 www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.

rief Description:

The Clinical Data Integration and Standards (CDI&S) group is accountable for data engineering and data pipeline activities within the Integrated Data Analytics and Statistical Programming (IDASP) group, primarily involving SDTM transformations for clinical trial and real-world data.

The Principal Statistical Programmer provides Statistical Programming project and technical leadership on CDI&S projects, and supports other CDI&S team members. They are responsible for the development and quality of all aspects of CDI&S deliverables on their assigned projects in accordance with departmental SOPs and guidelines. They delegate tasks appropriately and track progress. The Principal Statistical Programmer may also construct estimates of project resource requirements and timelines and routinely briefs management on accomplishments, status of projects, and any issues.

Essential Functions/Responsibilities

• Attend multi-disciplinary team meetings, representing the CDI&S function.
• Create or review and approve statistical programming plans at study and project level.
• Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, etc.).
• Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
• Implement in-house data standards.
• Develop software validation procedures and test plans, as necessary.
• Create and document archives of software, outputs, and analysis files.
• Create and maintain department SOPs and guidelines related to clinical programming.
• Oversee work of internal contract programmers and external vendors.
• Provide time and resource estimates for project planning.

Required Knowledge, Skills, and Abilities

• Minimum of 7 years of experience in developing software for clinical trials using the SAS system. Experience in real-world data a plus.
• Skilled in programming with SAS. Basic knowledge of additional programming languages such as R or Python.
• Good knowledge of statistics and general drug development processes. Basic knowledge of the Oncology drug development process and data structures is a plus.
• 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.
• Expert knowledge of SDTM and Define-XML standards. Knowledge of CDASH and ADaM a plus.
• Solid verbal and written communication skills.

Required/Preferred Education and Licenses

• Bachelor’s Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; Master’s Degree preferred.

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 ONLY

Jazz 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 anticipated base pay range is $128,000-$168,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.

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: https://careers.jazzpharma.com/benefits

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