Stats/SDTM Programmer in Bangalore, भारत

Job Description : Role : Stats Programmer / SDTM ProgrammerExperience : 8 to 13 YearsKey Responsibilities : - Develop SAS programs for analysis datasets (ADaM/SDTM) and TLF outputs.- Validate analysis datasets and outputs.- Support e-submission preparation and review.- Review key planning documents (SAP, data plans) and assess programming impacts.- Interact with vendors for standards and file transfers.- Ensure high-quality GBDS deliverables aligned with regulatory standards.- Identify efficiency and consistency improvements.- Lead programming assignments independently.- Support process improvement https://jobeax.com/link/GTNZKF2kxpVUFhTn Skills : - Bachelors degree in Statistics, Biostatistics, CS, Mathematics, or Life Sciences.- Minimum 8 years of programming experience in clinical research.- Strong analytical programming proficiency.- In-depth understanding of CDISC, relational databases.- Experience with MS Office, XML, Pinnacle 21.- Expertise in upstream data handling (eDC, SDTM).- Experience producing ADaM datasets, https://jobeax.com/link/UE15fSbKOKY7scWI, submission deliverables.- Knowledge of regulatory standards, clinical tests, and terminology.- Strong team collaboration https://jobeax.com/link/Cexs453KRiH2S1rJ : - 8+ years of clinical/statistical programming experience.- Experience supporting regulatory filings (NDA/BLA/MAA).- Experience with R and Linux OS. (ref:hirist.tech)