SAS Programmer

Therapeutic Area: Oncology, Neuroscience

Study Type: all phases of study

Tasks:

●Coordination of SDTM dataset programming activities carried out by company's subcontractor to ensure the quality of deliverables and adherence to deadlines

●Quality control of SDTM databases ( eg. Pinnacle 21 ) and review of regulatory documents (specifications, sDRG, Define…)

●SDTM SAS Programming Cross-functional achievement

●Conduct database transfers within the framework of clinical studies or for data sharing with external partners

●Submission package preparation and support during submission process and regulatory inspection

Required Skills:

●Between 5 and 10 years of experience in clinical data management with CDISC programming

●Knowledge of applicable regulatory requirements in clinical research, Good Clinical Practices (GCP), ICH guidelines, Good Data Management Practices, and CDISC requirements.

●Significant experience in programming CDISC-SDTM data formats

●Experience in Submission Package Preparation and management

●Good knowledge of information systems and database structure

●Project coordination skills, Analytical and problem-solving skills

●Autonomous, organized, meticulous, attention to detail

●Strong commitment to quality

●Ability to synthesize and communicate

●Fluent English