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. Brief Description: The Integrated Data Analytics and Statistical Programming Group (IDASP) within the Department of Data sciences is responsible for developing software for the analysis of clinical study data in accordance with departmental SOPs and guidelines. Essential Functions
Attend multi-disciplinary team meetings, representing the 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.)
Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to 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.
Create and maintain department SOPs related to clinical programming.
Oversee work of internal contract programmers and external vendors.
Create or review for accuracy, any reviewer guides and define.xml documents for clinical data packages.
Writes and/or implements specifications and oversees completeness of relevant documentation.
Minimum Requirements
Bachelor's Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; Master's Degree preferred
Minimum of 3 years of experience in developing software for clinical trials using the SAS system
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
Familiarity with CDISC standards, including SDTM and ADaM models
Solid verbal and written communication 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.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment \r\nwithout regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.\r\n 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. \r\nFor this role, the full and complete base pay range is $108,000-$162,000. 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. \r\nAt 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. \r\nThe 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
