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.
Strong hands-on experience with SAS Base Programming.
Expertise in:
SAS Macros
PROC SQL
Data Step Programming
Statistical procedures
Data validation and QC programming
Strong experience working with:
SDTM
ADaM
CDISC Standards
TLF Programming
Experience in clinical trial phases (Phase IIV).
Positive understanding of clinical trial processes and regulatory requirements.
Experience working with large clinical datasets and complex programming requirements.
Knowledge of submission standards and regulatory datasets. .
