Nimmy Xavier

About Nimmy Xavier

An enthusiastic and detail-oriented Statistical Programmer with over two years of experience in a CRO, specializing in applying CDISC standards in Phase l to Phase lII clinical trials. Skilled in developing ADaMs and creating safety and efficacy listings and tables for regulatory submissions. Proven ability to work effectively with biostatisticians and clinical teams to ensure data integrity and quality standards are met. Proficient in SAS programming and possessing strong analytical skills, contributing to the successful completion of clinical studies.Skilled in: Base SAS - SAS Procedures, SAS Functions, SAS Macro, SQL, SAS/STAT, R, SPSS, Tableau and ExcelTherapeutic Areas: Cardiovascular, Immunology, Opthalmology

Experience

1. Associate Statistical Programmer

   IQVIA

   Apr 2025 — Present · Kochi, IN

   Developed and validated ADaM datasets following CDISC and sponsor specific standards.Created safety and efficacy listings and tables. Performed QC of Outputs ensuring accuracy and traceability through documentation and log reviews.Performed dataset validation using Pinnacle 21 and resolved reported compliance issues.Worked as a co-lead, handling key project processes and ensuring smooth execution of deliverables.Collaborated with biostatisticians and clinical data managers to ensure data integrity and accuracy throughout the programming process.Assisted in the preparation of ADRG by documenting dataset-level metadata, derivation logic, and key analysis details for regulatory submission.Supported multiple deliverables - IND, DSUR, PBRER, ISS, ISE

Education

• Mahatma Gandhi University

  Bachelor's degree, Mathematics

• Cochin University of Science and Technology

  Master of Science - MS, Statistics