Ganji Sai Kumar
Statistical Programmer | SAS/R/SQL/Macro | Clinical Trials | CDISC/SDTM/ADaM/TLFs | Data Analysis & Reporting | CRO
- Role
- Clinical Programmer at Mars
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Ganji Sai Kumar
I am a detail-oriented and results-driven Statistical Programmer with 3+ years of experience in oncology and dermatology studies in the pharmaceutical and CRO industries, specializing in clinical trial data analysis, reporting, and regulatory submissions. I have a strong background in programming and validating datasets, TLFs (Tables, Listings, and Figures) aligned with Statistical Analysis Plans (SAPs), and implementing CDISC standards (SDTM and ADaM) across Phases I–IV clinical trials. A key highlight of my experience includes working on Integrated Summary of Safety (ISS) studies, where I supported the development and validation of integrated ADaM datasets and generated submission-ready outputs for regulatory agencies such as the FDA and EMA guidelines. I collaborated closely with biostatisticians, Clinical team and regulatory teams to ensure timely and accurate delivery of safety analyses across multiple studiesI am seeking to contribute my expertise in statistical programming and expand my skill set in data analytics, R programming, and advanced statistical techniques to drive impactful results in healthcare research.* Areas of ExpertiseClinical Trial Programming & ReportingCDISC Standards Implementation (SDTM, ADaM)Statistical Data Analysis & ValidationTLF Programming (Tables, Listings, Figures)Regulatory Submissions (FDA, EMA)Data Cleaning & Quality ControlDataset Compliance Validation (Pinnacle 21)Cross-Functional Collaboration (Biostatistics, Data Management, Clinical Teams)* Core SkillsSAS Programming (Base & Advanced)CDISC Standards (SDTM, ADaM)Pinnacle 21 for Compliance ChecksTLF Generation (Tables, Listings, Figures)Statistical Data AnalysisData Validation & Quality ControlSQL for Data HandlingClinical Trial Data ManagementFDA/EMA Regulatory Submission SupportProblem Solving & DebuggingCollaboration with Cross-Functional TeamsR Programming (Basic)Excel & Advanced MS Office
Experience
Clinical Programmer
Dec 2025 — Present · Hyderabad, IN
Education
Kakatiya University
Bachelor of Commerce - BCom, Computer applications
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