Jan 2023 – May 2024
Clinical Trial Data Analyst
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.
-- Adverse events that start before the subject's first doseSELECT ae.usubjid, ae.aeterm, ae.aestdtc, ex.first_doseFROM aeJOIN (SELECT usubjid, MIN(exstdtc) AS first_dose FROM ex GROUP BY usubjid) ex ON ae.usubjid = ex.usubjidWHERE ae.aestdtc < ex.first_dose;
