Clinical SAS Programmer

We are seeking an experienced and detail-oriented Clinical SAS Programmer to support statistical programming activities for clinical trials in compliance with regulatory standards (CDISC, FDA, ICH). The ideal candidate will have 5–10 years of experience in SAS programming within the clinical research domain, with a strong understanding of clinical data standards and processes.

Key Responsibilities:

• Develop, validate, and maintain SAS programs for clinical trial data analysis, including datasets, tables, listings, and figures (TLFs).
• Generate SDTM and ADaM datasets as per CDISC standards.
• Collaborate with biostatisticians, data managers, and clinical teams to ensure programming accuracy and consistency.
• Perform quality control (QC) and peer reviews of SAS programs and outputs.
• Contribute to the development of statistical analysis plans (SAPs) and programming specifications.
• Support regulatory submissions (e.g., FDA, EMA) including eCTD deliverables.
• Troubleshoot and resolve issues related to data integration, transformation, and reporting.
• Maintain proper documentation in accordance with SOPs and regulatory guidelines.

Required Skills and Qualifications:

• 5–10 years of experience as a SAS programmer in the clinical trial or pharmaceutical industry.
• Proficient in Base SAS, SAS/STAT, SAS Macro, and SAS SQL.
• Strong experience with CDISC SDTM and ADaM standards.
• Familiarity with clinical trial phases, data structures, and regulatory requirements.
• Experience in handling datasets from EDC systems (e.g., Medidata Rave, Oracle Clinical).
• Good understanding of ICH-GCP, FDA/EMA regulatory guidance, and 21 CFR Part 11.
• Strong analytical, documentation, and communication skills.