· 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