Senior Clinical SDTM Programmer
Within Integrated Data Analytics & Reporting (IDAR) Clinical and Statistical Programming (C&SP) we are looking for individuals with the motivation to contribute to the growth of our Clinical Programming team. The Clinical Programming team within C&SP is responsible for SDTM submission-ready deliverables (SDTM specifications, aCRF, datasets, xpt, define.xml, cSDRG), back-end edit checks, listings, tables, to support data cleaning and review activities.
The position is responsible for oversight or the development of one or more clinical data management trial activities of moderate to high complexity/criticality. Including data model specifications, data stream integrations and transformation of source to internal data models and/or CDISC submission ready SDTM tabulation packages (aCRF, define.xml, cSDRG, etc). Creates and executes edit check programs, listings and report solutions to aid in monitoring of safety, risk, compliance and ensures quality data review.
This position is a member of the clinical programming team and is capable of supporting programming
activities with minimal guidance and may contribute to departmental innovation and process improvements.
May perform reporting solutions role creating study-specific reports translating clinical study team needs into specifications aggregating clinical data sources into custom data and report to monitor safety, risk and compliance.
- Create and/or review internal Data Review Model (DRM) and SDTM mapping specifications, aCRF, datasets, define.xml, cSDRG for stakeholder use (data cleaning, medical review, central monitoring, adaptive decision making, etc.)
- Create back-end edit checks, data cleaning and review listings, tables
- Independently manages interfaces and escalations with cross-functional project teams.
- Develop and maintain working knowledge and expertise in programming languages utilized in clinical programming (SAS, SQL, etc.) and apply continuous learning as part of next generation data strategy (R, Python, Scala, Java, etc.).
- Bachelor’s degree in Computer, Data or Life Sciences or equivalent work experience is required; Master’s degree preferred
- 4+ years of relevant experience in pharmaceutical industry is desired, experience in other industries in programming role will also be considered
- In-depth knowledge of protocol, current clinical drug development processes preferred
- In-depth knowledge of data structures and relevant programming languages for data manipulation and reporting. May include SAS, R, Python, etc. Knowledge of SAS is required.
- Therapeutic area knowledge in Oncology, Immunology and Early Development plus
- Demonstrated written and verbal communication skills
- Aptitude and motivation to learn new technologies and make appropriate recommendations for consideration is preferred
- Vendor management oversight experience
Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-Netherlands, Europe/Middle East/Africa-France, Europe/Middle East/Africa-United KingdomOrganization
Janssen Pharmaceutica N.V. (7555)Job Function
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