PRAVEEN KUMAR
Senior Statistical Programmer II
Hyderabad
Summary
• 7+yearsofexperienceasaStatisticalProgrammerintheclinical/CROdomain,spanningOncology,Immunology,and rare disease therapeutic areas.
• Stronghands-onexpertisedevelopingSDTMdomains(AE,CM,MH,TU,TR,RS,DM,DS)andADaMdatasets (ADTTE, ADTR, ADRS) in compliance with CDISC standards.
• ExtensiveexperiencegeneratingTLFs(tables,listings,andfigures)fortumorresponse,adverseevents,andsurvival analyses, including RECIST v1.1-based efficacy endpoints (PFS, OS, response rates).
• Skilledincomplextime-to-eventderivations,censoringruleimplementation,anddatelogicforefficacyandsafety analyses.
• ProficientinSASdatamanipulation:FORMATS/INFORMATS,MERGE,PROCAPPEND,PROCDATASETS, PROC SORT, PROC TRANSPOSE, and ODS output (HTML, CSV, RTF).
• SolidunderstandingofProtocol,SDTMImplementationGuide(IG),CRFannotation,andPinnacle21validation.
Overview
8
8
years of professional experience
Work History
Senior Statistical Programmer II
Ephicacy Lifescience Analytics Pvt. Ltd.
08.2025 - Current
- Managed DBL programming for 8 SDTM studies and 4 TLF studies (Phase I–III, oncology) to ensure compliance with regulatory standards.
- Generated Pinnacle 21 validation reports and authored SDRGs to maintain data integrity and support regulatory submissions.
- Programming SDTM datasets (IG 3.2) and ADaM datasets (ADQS, ADVS, ADSL, ADAE).
- Performed safety reporting using SAS-based tables, listings, and figures to provide comprehensive insights for clinical trial outcomes.
- Developing custom SAS macros to automate reporting tasks.
Statistical Programmer II
Parexel International Pvt. Ltd.
10.2024 - 08.2025
- Created SDTM-compliant datasets and developed mock shells for TLF programming to support accurate data presentation.
- Applied SAS statistical procedures (PROC UNIVARIATE, FREQ, MEANS, TTEST).
- Performed validation and QC of tables and listings.
- Extracted CRF data and generated reports/graphs for stakeholders to facilitate informed decision-making.
- Performed validation and QC of tables and listings to ensure data integrity and compliance.
Senior Analyst
R1 RCM Global Pvt. Ltd.
02.2019 - 09.2024
- Imported and integrated multisource data into SAS datasets.
- Produced analysis-ready tables, listings, figures, and reports.
- Performed data cleaning and summary statistics to ensure data integrity and accuracy.
- Derived new variables and created graphical outputs to support decision-making in Phase II–IV trials.
Education
Diploma in Software Engineering -
NIIT
01-2009
Bachelor of Science (B.Sc.) - BZC
Prathibha Degree College, Osmania University
01-2007
Skills
Clinical data programming
Safety reporting
Clinical trial data analysis
Data cleaning
Regulatory compliance
CDISC SDTM
CDISC ADaM
Pinnacle 21 validation
Definexml authoring
SDRG authoring
TLF development
SAS macros
Statistical programming
R programming
PROC UNIVARIATE, FREQ, MEANS, TTEST
Timeline
Senior Statistical Programmer II
Ephicacy Lifescience Analytics Pvt. Ltd.
08.2025 - Current
Statistical Programmer II
Parexel International Pvt. Ltd.
10.2024 - 08.2025
Senior Analyst
R1 RCM Global Pvt. Ltd.
02.2019 - 09.2024
Diploma in Software Engineering -
NIIT
Bachelor of Science (B.Sc.) - BZC
Prathibha Degree College, Osmania University