Clinical Trial Data Analyst
Jan 2023 – May 2024
Synergen Bio Pvt. Ltd. | Pune, India
- Mapped raw EDC data into CDISC SDTM and ADaM compliant datasets using Python (pandas) across 5 Phase I/II studies, supporting regulatory-ready submission datasets for DCGI and global filings.
- Wrote Python scripts (NumPy, SciPy) to calculate Cmax, Tmax, and AUC and test bioequivalence against reference formulations using 90% confidence intervals for 5 studies.
- Developed SQL validation checks to flag data discrepancies (such as adverse event onset dates before dosing) across 600+ queries, reducing database lock time by 22%.
- Built SQL views with CTEs and window functions to report dropout patterns, screen-failure ratios, and protocol deviations, delivered as dashboards to Principal Investigators.
- Automated AE/SAE data cleaning and MedDRA coding on 1,500+ safety records, improving coding efficiency by 18%; reviewed audit trails to support ALCOA+ and Schedule Y compliance.