Lead Sdtm Programmer

Job summary
Lead SDTM Programmer position in the SDTM Programming & Submission departmentResponsible for ensuring compliance, promoting knowledge exchange, and solving methodological or technical tasksRequires experience in life sciences, clinical data management, and CDISC SDTM
Job seniority: associate level
Responsibilities
• Ensure alignment of clinical trial design across trials within projects• Create and submit Study Data Tabulation Model (SDTM) packages• Present in conferences and network within the pharmaceutical industry• Drive cross-functional initiatives and lead projects and people• Maintain communication and adherence to standards• Facilitate implementation of business processes
Requirements
• Minimum 6-8 years of experience in the Life Sciences industry• 4 years of experience in Clinical Data Management with CDISC SDTM• Expert knowledge of clinical data management activities and systems• Experience with programming languages (SAS, R, Python, AI/ML)• Experience in project management and stakeholder management• Knowledge of GxP and drug development guidelines
Key Skills Needed
• Experience with programming languages (SAS, R, Python, AI/ML)• Knowledge of GxP and drug development guidelines