Principal Statistical Programmer

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: October 13, 2021

Job Description:

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.

The Statistical Programming Group within the Department of Biometrics 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.
• 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 7 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.

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