Data Management & Biostatistics
Data Management & Biostatistics — Precision Data, Rigorous Analysis
- EDC — eCRF design on Medidata Rave, Oracle Clinical, REDCap, OpenClinica.
- CDISC Standards — SDTM/ADaM datasets, Define.xml, Pinnacle 21 validation.
- Statistical Analysis — SAP development, interim/final analyses, ANCOVA, survival analysis, non-inferiority/equivalence testing.
- Data Cleaning — Automated edit checks, medical coding (MedDRA, WHODrug), external data reconciliation.
- Randomization — IWRS/IXRS design, stratified randomization, unblinding procedures.
- CSR-Ready Deliverables — Publication-quality TLFs for regulatory submissions.
