Job Description

• Develop and maintain SAS programs to import, clean, and validate clinical trial data.
• Use R for data manipulation, analysis, and visualization.
• Perform statistical analyses in accordance with study protocols and analysis plans.
• Generate tables, listings, and figures (TLFs) using SAS and R.
• Create and QC statistical outputs and clinical study reports for regulatory submissions.
• Document programming activities and ensure compliance with Standard Operating Procedures (SOPs).
• Work closely with biostatisticians, data managers, and clinical researchers.
• Provide programming support for ad-hoc analysis requests and exploratory data analyses.
• Perform rigorous quality checks on all deliverables.
• Maintain annotated datasets and ensure traceability of data processing.

• Bachelor's or master's degree in Statistics, Computer Science, Biostatistics, or a related field.
• Minimum of 3 years of clinical SAS programming experience, with a strong background in R.
• Proficiency in SAS and R, including data step programming, PROC SQL, and R packages for data analysis.
• Experience with CDISC standards (SDTM, ADaM).
• Knowledge of clinical trial processes and regulatory requirements (e.g., FDA, EMA).
• Strong analytical and problem-solving skills.
• Excellent communication skills, both written and verbal.

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