A senior programmer is sought to support regulatory submission activities and produce datasets in a clinical and non-clinical environment. Strong knowledge of CDISC SDTM and ADaM guidelines is required, as well as expertise in SAS programming within the pharmaceutical industry.
Key Responsibilities
* Develop and validate complex datasets, including efficacy outputs, labs, and SDTMs.
* Become an independent technical expert and provide consultancy, advice, and training on SDTM, ADaM, and CRT standards.
* Create, review, and update complex dataset specifications for single or multiple studies.
* Implement standard macro libraries and develop archiving systems and processes.
* Liaise with study statisticians and project managers regarding resourcing and deliverables.
Qualifications
* Educated to BSc or above in Computer Science, Mathematics, or a Science-related discipline.
* SAS programming experience within the pharmaceutical industry.
* Good awareness of clinical trial design and implementation, as well as regulatory submissions and associated industry guidance.
About Next Aviation SL
This role will involve remote work, occasional travel to events, and the opportunity to develop company-wide training programs and create processes and SOPs.