Develop, maintain and support standard software programs (using SAS and other technologies) that support monitoring, data management and data standards for preclinical, clinical and epidemiological studies and the Data Repository. This role ensures his/her deliverables are at the top of industry standards with respect to quality, performance and timelines.
- Provide SAS programming support (i.e. Writing technical specifications, Developing, Maintenance, validation) for programs that support monitoring, data management and data standards for clinical trial data.
- Use other tools (e.g. PL/SQL, Cognos, Web technologies) to create programs when appropriate (and when skilled with the tool).
- Provide direct global user support and trainings and troubleshoot problems on Standards programs.
- Provide professional programming input for new program or program enhancement requests
- Act as data conversion programmer.
- May work as independent programmer on standard programs or as part of a team under supervision of a team leader on large and complex projects.
- Support programming for process improvement projects and may act as Subject Matter Experts in supporting Business Excellence in the implementation of new processes, trainings, systems, vendor quality assessments, audits and inspections.
- Fluent English (spoken and writte)
- French and Italian a plus
- Good analytical skill
- Good interpersonal and communication skills
- Good analytical, problem solving, change management and project delivery skill
- Accurate worker with attention to detail
- Excellent programming skills in SAS is required, skills with other relevant tools is desired
- Good knowledge of CDISC Standards (CDASH, SDTM), ADaM knowledge as a plus
- Proven ability to objectively review vendor software to maintain effectiveness in rapidly changing IT environment, ability to participate in external Pharma groups on standard programming related matters (e.g., CDISC)
- Strong knowledge / experience in IT tools, statistical software. and validation methodology
- Ability to understand how to apply regulations including ICH-GCP to the area under responsibility
- Basic understanding of clinical data