Sandhiya Shree

Statistical Programmer with 2+ years of SAS programming experience (BASE, STAT, MACRO, SQL, GRAPH, IML) across 3–4 concurrent Phase I/II clinical studies in oncology and neurology (ALS), delivering 50+ SDTM and ADaM datasets to submission-ready standard. Designed a parameterized macro framework for TLF generation, imputations, and SDTM reference-date derivation, and optimized SAS processing for datasets exceeding 50,000 records. Proficient in end-to-end CDISC data package delivery — including define.xml, aCRF, Reviewers Guide, value-level metadata, and controlled terminology — validated through Pinnacle 21.

Skilled in authoring programming specifications, interpreting Statistical Analysis Plans, and producing TLFs for CSRs, DSURs, and PBRERs in GxP-compliant, blinded and open-label environments.

Statistical Programmer - Zifo RnD Solutions

(2024-05)

• Programmed 50+ SDTM and ADaM datasets (ADSL, ADAE, ADRS, ADTTE, ADLB, ADCM) across 3 Phase I/II clinical studies in oncology and ALS, achieving zero critical findings at Pinnacle 21 validation across all submissions.
• Designed a parameterized macro framework — including RFSTDTC, RFENDTC, and RFXENDTC derivation logic within the DM domain — reused across studies to generate TLFs, drive imputation logic, and standardize output structure.
• Delivered submission-ready CDISC data packages (define.xml, aCRF, Reviewers Guide, CRT packages, value-level metadata) for 3 IND-stage Phase I/II studies, supporting submission-ready deliverables aligned with regulatory and CDISC controlled terminology standards.
• Authored programming specifications for SDTM, ADaM, and TLF outputs across oncology and ALS studies, standardising specification templates to reduce specification-to-code cycle time by ~20%.
• Generated 100+ Tables, Listings, and Figures (TLFs) supporting safety and efficacy analyses for CSRs, DSURs, and PBRERs across oncology and ALS indications, applying PROC TABULATE and PROC IML for advanced summary reporting and custom statistical computations.
• Formatted TLFs to targeted publishing requirements — including Clinical Study Reports, ClinicalTrials.gov, and EudraCT lay summaries — delivering zero reformatting cycles post-QC review.
• Concurrently managed programming deliverables across 3–4 active Phase I/II studies, including datasets exceeding 50,000 records, maintaining on-time delivery through prioritization and timeline tracking.
• Performed independent double-programming QC across all dataset and TLF outputs, maintaining a 100% QC pass rate and resolving discrepancies prior to delivery.
• Validated 50+ SDTM and ADaM datasets against Pinnacle 21, peer-reviewed datasets and CRT packages authored by colleagues, and delivered refresher training sessions on SDTM/ADaM standards and macro usage.
• Coordinated with statisticians and cross-functional programming teams to clarify SAP requirements, resolve dataset issues, track deliverables, and support interim and final analysis timelines.
• Delivered exploratory and post-hoc analyses contributing to integrated clinical database development and cross-study SDTM/ADaM pooling exercises.

Analyst — Validation & Compliance - Zifo RnD Solutions

(2024-01 - 2024-12)

• Delivered 900+ OQ test scripts for Watson LIMS and LabVantage LIMS in GxP-regulated environments, achieving zero audit failures across all customer-facing validation cycles.
• Reduced manual testing effort by 30%, improved defect detection by 25%, and shortened audit turnaround by 15% by designing and executing Playwright-based automation testing for compliance workflows.
• Ensured 100% traceability coverage across validation lifecycles by authoring test scripts, traceability matrices (TRM), and user documentation aligned to 21 CFR Part 11, GAMP 5, and SOP standards.

B.Tech - Biotechnology - Rajalakshmi Engineering College (2020-08 - 2024-05)