AddressDescription
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 and follow @JazzPharma on Twitter.
Brief Description:
The Senior Principal Statistical Programmer provides Statistical Programming technical leadership and support to team members. The Senior Principal Statistical Programmer is responsible for developing all aspects of statistical programming deliverables for the analysis of clinical study data in accordance with departmental SOPs and guidelines. Delegates tasks appropriately and tracks progress. The Senior 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. In addition, the Senior Principal Statistical Programmer will be a designated member of CTWG team in the role of lead Statistical Programmer for clinical trial(s).
Essential Functions
- Lead statistical programming activities as product lead for full development project or groups of projects in Oncology Therapeutics.
- Attend multi-disciplinary team meetings, representing the statistical programming 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, SAPs, etc.).
- Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
- Participate and/or lead in the development and implementation of SAS programming standards, SOPs and work instructions, including program validation and documentation.
- Develop and validate programs (SAS or R) to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies.
- Collaborate with stakeholders and R&D cross functional team members to standardize, maintain and implement the data transformation and statistical analysis requirements.
- Assist statisticians by suggesting algorithms to address novel analysis requests.
- Create and document archives of statistical programming deliverables, outputs, and analysis files.
- Create and maintain department SOPs related to statistical programming.
- 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.
Required Knowledge, Skills, and Abilities
- Minimum of 9 years of experience in developing statistical programming deliverables for clinical trials using the SAS system.
- Skilled in programming with SAS. Knowledge of additional programming languages a plus.
- Good knowledge of statistics and Oncology drug development process.
- Ability to manage multiple complex projects and assess resource needs.
- Excellent verbal and written communication within the Biostatistics group and across other functional areas.
- Significant experience in developing SDTM, ADaM and TFLs using SAS or other tools.
- Expertise with CDISC standards.
- Good understanding on clinical standards as well as clinical data sets from major EDC systems (e.g., Medidata Rave, INFORM), safety systems (Argus), and CTMS systems.
- 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.
Required/Preferred Education and Licenses
- Bachelors Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; Masters 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 $148,000-$194,250. 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:
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