Statistical Programmer - Junior level

Role Summary

We are seeking a Statistical Programmer with 12 years of experience to support clinical trial programming activities within a CRO environment. The role focuses on developing high-quality statistical outputs in compliance with CDISC standards, SOPs, and regulatory requirements, while working closely with biostatisticians and cross-functional teams.

Key Responsibilities

• Develop and maintain SAS programs for clinical trial data analysis
• Create and validate SDTM and ADaM datasets in accordance with CDISC standards
• Generate Tables, Listings, and Figures (TLFs) for clinical study deliverables
• Perform QC and independent validation of datasets and outputs
• Support interim, final analyses, and Clinical Study Reports (CSRs)
• Ensure adherence to SOPs, GxP guidelines, and regulatory standards
• Maintain complete programming documentation and version control
• Collaborate with biostatistics, data management, and clinical teams

Required Skills & Experience

• 12 years of hands-on experience in statistical programming within a CRO
• Strong proficiency in SAS (Base SAS, Macros)
• Working knowledge of CDISC (SDTM, ADaM)
• Understanding of the clinical trial lifecycle
• Experience working in a regulated, deadline-driven environment
• Good analytical, problem-solving, and communication skills