Snapshot
Driving regulated trial programs with validated SDTM and ADaM datasets, reproducible macro systems, and audit-ready statistical reporting.
10+
Years in Clinical Programming
5
Therapeutic Areas
I-IV
Clinical Trial Phases
Clinical Data Programming Excellence
Rajini Jonna
Sr. SAS Programming Analyst at Johnson and Johnson
10+ years of SAS programming experience across Phase I-IV clinical trials, from CDISC mapping to submission-ready reporting.
About
Precision-oriented programming for high-stakes clinical studies
Senior SAS programming specialist with 10+ years of experience in programming, analysis, and reporting for clinical trial studies using SAS in Windows environments.
I have worked across cardiovascular, oncology, and immunology clinical trials with strong exposure to the drug development lifecycle in Phase I, II, III, and IV studies.
My core strength is building and validating SDTM and ADaM datasets, then generating high-quality tables, listings, figures, and graphs aligned with SAP requirements.
I bring strong CDISC SDTM mapping knowledge, hands-on experience with OpenCDISC validator issue resolution, and deep reporting expertise using SAS/ODS in EXCEL, RTF, HTML, and PDF formats.
I routinely use PROC REPORT, PROC SUMMARY, PROC MEANS, PROC FREQ, DATA step, DATA _NULL_, and macro programming to deliver ad hoc and scheduled outputs.
I am proficient in debugging and validation, familiar with FDA regulations, ICH guidelines, and GCP requirements, and effective both independently and in cross-functional teams.
Skillset
Deep clinical programming capabilities, structured by outcome
A focused skill matrix across SAS execution, CDISC standards, reporting quality, and regulatory alignment.
SAS Programming
95%- Base SAS
- SAS Macro Development
- Macro Debugging
- DATA Step and DATA _NULL_
- PROC REPORT / SUMMARY / MEANS / FREQ
Clinical Data Standards
96%- CDISC SDTM
- ADaM Dataset Development
- Annotated CRFs
- Metadata Creation
- OpenCDISC Validation
Statistical Reporting
93%- TLF and TLG Generation
- SAP-Based Reporting
- Safety and Efficacy Analysis
- Ad Hoc Statistical Reports
- SAS/ODS Output (EXCEL, RTF, HTML, PDF)
Regulatory and Collaboration
91%- IND and E-Submission Files
- FDA / ICH / GCP Awareness
- OpenCDISC Validator Resolution
- Cross-Functional Reviews
- Independent and Team Delivery
Experience
A decade of clinical programming impact
Scroll through major roles and expand each milestone for key outcomes and responsibilities.
- Led development, quality control, and documentation of statistical SAS programs for clinical trial studies.
- Supported planning and execution of SAS programming activities and project requirements.
- Built and validated ADaM datasets and submission-ready TLF outputs.
- Developed study-specific macros and maintained complete documentation standards.
Work Highlights
Key contributions translated into measurable delivery value
Derived from real program work across regulated clinical study environments.
Submission-Ready ADaM and SDTM Delivery
Built and validated SDTM and ADaM assets with strong mapping quality and documentation for regulated studies.
Impact: Reliable analysis-ready data for downstream statistical reporting
ADaMSDTMValidation
SAS/ODS Reporting at Scale
Generated clinical outputs in EXCEL, RTF, HTML, and PDF through SAS/ODS for recurring and ad hoc reporting needs.
Impact: Consistent, presentation-ready outputs for study teams and stakeholders
SAS/ODSReportingOutput Automation
Procedure and Macro Expertise
Applied PROC REPORT, SUMMARY, MEANS, FREQ, DATA step, and macro programming to meet SAP-driven analysis timelines.
Impact: Faster turnaround with reproducible and high-quality deliverables
PROC REPORTMacrosSAP
Compliance and Quality Control
Worked with OpenCDISC validator findings and robust QC practices aligned with FDA, ICH, and GCP expectations.
Impact: Lower submission risk and stronger data confidence
OpenCDISCQCRegulatory
Education
Academic Foundation
Formal training that anchors Rajini's analytical and scientific approach to programming in clinical research.
Degree
Master's in Biotechnology
JNTU, India
Contact
Let us connect on upcoming clinical programming opportunities
Reach out directly through the channels below.
Contact Details
Open to strategic roles in statistical programming, submission delivery, and clinical data quality leadership.