SOWJANYA ENTURI
Summary
Clinical SAS Programmer with over 6 years of experience supporting Phase I–III clinical trials across diverse therapeutic areas. Highly experienced in SAS programming for SDTM and ADaM datasets, TLF development, database mapping, validation, Define XML, CRF Annotation, P21 Report analysis, Submission package and edit checks. Strong collaborator with Data Management, Biostatistics, and Statistical Programming teams, delivering high-quality, compliant outputs aligned with CDISC standards and regulatory requirements.
Overview
7
7
years of professional experience
Work history
Clinical SAS Programmer
HCL Tech
2019.06 - 2024.05
- Performed end-to-end CDISC SDTM dataset creation and migration for multiple studies, following SDTM Implementation Guide and mapping specifications.
- Developed ADaM datasets (ADSL, BDS, OCCDS) for multiple studies in accordance with statistical analysis plans and regulatory standards.
- Designed, implemented, and validated SAS programs for creation of analysis datasets, tables, listings, and figures (TLFs) in support of Phase I–III clinical trials.
- Provided critical clinical programming support across multiple studies, ensuring high-quality and timely delivery of analysis outputs.
- Programmed, validated, and maintained mapped clinical databases using SAS, including ongoing updates based on database changes and study requirements.
- Programmed SAS edit checks for internal and external data to identify data inconsistencies, data quality issues, and mapping discrepancies.
- Developed and utilised SAS macro programs for validation activities, including PROC COMPARE analysis, mapping updates, and identification of data and programming issues.
- Conducted analysis dataset validation and independent quality control to ensure accuracy, consistency, and compliance with specifications.
- Analysed SAS programs to identify root causes of errors and implemented corrections, enhancements, and environment-related updates as required.
- Authored and maintained comprehensive documentation for SAS programs, specifications, validation results, and change controls in line with SOPs.
- Collaborated closely with Data Management to review database specifications, support data transfers, and resolve data-related issues throughout the study lifecycle.
- Worked in partnership with statisticians and Data management teams to ensure accurate interpretation of analysis requirements and timely delivery of study outputs.
- Reviewed and annotated CRFs using raw data and study protocols; provided feedback on CRF annotations, edit checks, and validation analysis plans.
- Supported P21 report generation and analysis for regulatory submission activities.
- Produced standard, study-specific, and ad hoc reports using SAS ODS in RTF, PDF, and HTML formats.
- Developed and maintained standardised SAS programs within organisational tools to improve efficiency, consistency, and reusability across projects.
- Good knowledge and experience on Define.XML, Metadata, Data Dictionary and Controlled Terminology.
- Successfully supported Phase I–III studies from protocol review through final reporting, consistently meeting project timelines and deliverables.
SAS programmer trainee
Sun Icon Systems Pvt Ltd
2017.09 - 2019.06
- Developed and validated SAS programs for SDTM datasets, analysis datasets, and TLFs across multiple clinical studies.
- Created SDTM datasets by mapping raw data in accordance with CDISC SDTM Implementation Guide and study specifications.
- Programmed SAS edit checks and validation programs to identify data quality, mapping, and programming issues.
- Collaborated with statisticians, clinical programmers, and Data Management to resolve data issues and support data transfers.
- Performed self-validation and peer review of SAS programs and datasets to ensure compliance and accuracy.
- Developed annotated CRFs and reviewed CRF annotations, edit checks, and validation plans.
- Supported P21 report generation and regulatory submission activities.
Education
Bachelor of Pharmacy -
Chebrolu Hanumaiah Institute Of Pharmaceutical Sciences
Skills
- SAS Programming (Base SAS, Advanced SAS, Macros, SQL, Proc Steps)
- CDISC Standards (SDTM, ADaM, Definexml)
- Tables, Listings & Figures (TLFs)
- Data Mapping, Validation, P21 Analysis
- Edit Checks & External/Vendor Data
- Clinical Database Maintenance and Submission package creation
- CRF Annotation & Review
- ICH-GCP Guidelines (E3, E6, E9)
- Cross-functional Communication
Timeline
Clinical SAS Programmer
HCL Tech
2019.06 - 2024.05
SAS programmer trainee
Sun Icon Systems Pvt Ltd
2017.09 - 2019.06
Bachelor of Pharmacy -
Chebrolu Hanumaiah Institute Of Pharmaceutical Sciences