01Key Responsibilities
Develop, validate, and maintain statistical programs for clinical trial data analysis and reporting.
Perform SAS programming activities including SDTM, ADaM datasets, TLFs (Tables, Listings, and Figures), and statistical outputs.
Create and validate datasets according to CDISC standards (SDTM/ADaM).
Develop complex SAS programs/macros for data manipulation, analysis, and reporting.
Perform programming for clinical study reports (CSR), regulatory submissions, and interim/final analysis.
Ensure compliance with SOPs, programming standards, and regulatory guidelines.
Review statistical programming specifications and translate requirements into programming solutions.
Perform quality control (QC) checks and validation of datasets and outputs.
Collaborate with statisticians, clinical data managers, and cross-functional teams.
Support regulatory submissions (FDA/EMA/PMDA) by preparing submission-ready datasets and outputs.
Troubleshoot programming issues and provide technical solutions.
Mentor junior statistical programmers and support best practices.
Required Technical Skills
710 years of experience in Statistical Programming / Clinical SAS Programming.
Robust hands-on experience with SAS Base Programming.
Expertise .
