Statistical Programmer II (SDTM)

Overview

Statistical Programmer II (SDTM) to support clinical research by developing and quality controlling SDTM datasets for regulatory submissions and study decisions.

What you'll do

• Review and provide feedback on Protocol and SAP related to SDTM mappings.
• Develop SDTM trial design domains.
• Program complex SDTM datasets.
• Debug simple to moderate SAS macros.
• Support the SDTM Lead.
• Assist with development and review of SDTM mappings and datasets while applying efficient programming techniques.
• Support process improvements through macro and application development.

What you'll need

• 3+ years of experience in SDTM statistical programming.
• Proficiency in SAS and knowledge of programming and reporting processes.
• Understanding of regulatory requirements and industry technical standards for clinical trial data.
• Experience developing SDTM trial design domains and complex SDTM datasets.
• Excellent written and verbal communication skills, including competency in written English.
• Strong organizational, teamwork, and project management skills.
• Bachelor’s or Master’s degree in a relevant discipline, or equivalent experience.

Nice to have

• Experience supporting SDTM Leads on clinical research studies.
• Graduation or equivalent degree in a relevant discipline.

Details

• Remote capacity.