• Design, develop, and validate statistical programs, datasets, and reporting outputs (tables, listings, and figures) for clinical trials in alignment with project requirements and regulatory standards.
• Build and maintain analysis datasets (ADaM) and study data tabulation models (SDTM) in compliance with CDISC standards, ensuring traceability and submission readiness.
• Develop, maintain, and optimize SAS programs, macros, and templates for clinical data review, reconciliation, and reporting to support both production and quality control (QC) workflows.
• Lead the review of key study documentation including statistical analysis plans (SAP), annotated CRFs, mock shells, and programming specifications to ensure consistency and alignment across deliverables.
• Engineer robust, auditable programming workflows and data traceability pipelines, adhering to Good Clinical Practices (GCP), ICH guidelines, and internal standard operating procedures (SOPs).
• Collaborate with biostatisticians, data managers, and clinical teams to identify programming needs, define deliverable requirements, and ensure timely, high-quality data outputs for regulatory submissions and publications.
• Create regulatory submission documents such as Define.xml, SDRG, and ADRG to support clinical study reports (CSRs) and electronic data submissions.
• Support external data integration and reconciliation through programmatic validation routines and automated data cleaning processes, enhancing the quality and reliability of study datasets.
• Participate in the continuous improvement of statistical programming standards, processes, and reusable assets to drive efficiency and consistency across studies and therapeutic areas.
• Provide mentorship and technical leadership to junior statistical programmers by conducting code reviews, sharing best practices, and contributing to group knowledge development.
• MS with 2 years of Experience
• Requires Master's degree or equivalent in Computer Science, Statistics or closely related field
Contact Person: [email protected] 
