Created in 2014, Excelya is a contract research organization (CRO).
We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates.
Our unique one-stop provider service model leveraging a full-service, functional service provider and consultancy allows our Excelyates to evolve across a wide range of projects.
Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field.
We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique
The Statistical Programmer is a member of the statistics team and contributes to programming tasks required for clinical trial analysis and reporting.
The Senior Statistical Programmer plays a lead role in performing all programming tasks required for clinical trial analysis and reporting.
Deeply acknowledges and strictly follows SOPs, ICH-GCP guidelines and appropriate local and international legislation.
Specification and efficient programming of CDISC conform or other data mapping, CDISC conform or other analysis data sets, tables, listings and graphs for clinical study reports, safety and other reports, and publications in close collaboration with statisticians.
Development of ad-hoc macros for data analysis and reporting.
Program validation and respective documentation.
Development of standard macros and tools for data analysis and reporting.
Development of programs for generation of randomization lists.
Coordination and supervision of programming activities among the project team including communication of timelines and ensuring that programming team members are following appropriate procedures and completing tasks as scheduled.
Consultancy with scientific investigators and statisticians to determine programming needs.
May undertake other tasks as they may be assigned by the supervisor that will concern any of the Excelya Group companies.
The assignment requires the following skills :
Bachelor or educational background in medical documentation or equivalent qualification in a field or discipline specified by the department in the preferences.
Experience : At least 5 years of professional experience as Statistical Programmer in the pharmaceutical industry or CRO directly related to the duties and responsibilities specified.
At least 5 years of SAS programmingAt least 5 years of SDTM programmingAt least 3 years of ADAM programmingAt least 2 years of submission package development
Knowledge of programming logic and code.
Team working skills.
Good command of English language.
Structured and accurate way of working and ability to maintain clear documentation.
Ability to work independently
Ability to consult with scientific investigators and statisticians to determine programming needs.
Ability to supervise and train staff, including organizing, prioritizing, and scheduling work assignments
Ability to consult with scientific investigators, interpret research requirements, and determine statistical analysis strategies.