Reference #: 11156
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 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
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