Summary
Overview
Work History
Education
Skills
Timeline
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SAMANVITHA

Morrisville,USA

Summary

Detail-oriented and highly motivated SAS Programmer with 3+ years of experience in clinical data analysis, statistical reporting, and regulatory submissions. Proficient in developing, validating, and maintaining SAS programs for data manipulation, statistical analysis, and reporting in compliance with CDISC standards (SDTM, ADaM). Strong analytical and statistical skills, with a focus on data manipulation, analysis, and generating reports in clinical and healthcare settings. Eager to contribute to team success through hard work, attention to detail, and excellent organizational skills.

Overview

5
5
years of professional experience

Work History

SAS Programmer

IQVIA
01.2024 - 04.2025
  • Assisted in setting up and configuration of Sycamore SCE to support statistical programming workflows for clinical studies.
  • Created Metadata repository folder structures in SCE environment for clinical studies.
  • Gained hands-on experience navigating Sycamore SCE for accessing and executing SAS programs in a validated clinical computing environment.
  • Integrated statistical tools (R, SAS, Python) into secure, validated environments tailored to user-specific workflows.
  • Developed and maintained access control models and audit logging in line with regulatory mandates (21 CFR Part 11).
  • Authored SOPs, technical configuration guides, and validation protocols to support both ongoing operations and regulatory audits.
  • Partnered with Clinical Data Management and Quality Assurance to ensure ongoing compliance and system optimization.
  • Performed routine system performance evaluations and introduced enhancements to support growing user demands.

SAS Programmer

BioClinAarc Pvt Ltd
01.2020 - 07.2022
  • Validated SAS programs used to generate derived and analysis datasets in accordance with the Statistical Analysis Plan (SAP) and project-specific requirements.
  • Developed and validated SAS programs for SDTM datasets based on approved specifications, ensuring compliance with CDISC standards.
  • Created and modified SAS programs to generate ADaM datasets such as ADSL, ADVS, ADLB, and ADAE, aligned with study protocols and statistical requirements.
  • Designed and validated Tables, Listings, and Figures (TLFs), including AESOC, AEPT, and AESOC/PT outputs, as specified in the SAP.
  • Collaborated closely with study statisticians and projects lead to gathering requirements, clarifying specifications, and ensuring timely and accurate deliverables.
  • Ensured all SAS programs adhered to established programming standards and validation procedures.
  • Verified that all program outputs were accurate, traceable, and compliant with the study specifications.
  • Maintained comprehensive documentation of programming activities, validation processes, and project updates in accordance with organizational and regulatory requirements.
  • Developed and maintained data files by importing raw data and modifying existing datasets using SAS data manipulation techniques (e.g., SET, MERGE, SORT, UPDATE, conditional logic).
  • Utilized a wide range of SAS procedures including PROC SORT, PROC CONTENTS, PROC FORMAT, PROC FREQ, PROC TRANSPOSE, PROC REPORT, PROC MEANS, and PROC TABULATE to support data analysis and reporting.
  • Performed SDTM mapping using specification documents to create domains such as DM (Demographics), EX (Exposure), and VS (Vital Signs).
  • Developed ADaM datasets and programmed TLFs for clinical endpoints, including Vital Signs and Electrocardiogram (EG) summaries, in accordance with SAP requirements.

Education

Master’s - Health Informatics

Governors State University
University Park, IL
05.2024

Skills

  • PSAS (Base, Macro)
  • SQL
  • Microsoft Excel
  • Data Cleaning
  • Statistical Analysis
  • Clinical Data Management
  • SDTM
  • R
  • Python

Timeline

SAS Programmer

IQVIA
01.2024 - 04.2025

SAS Programmer

BioClinAarc Pvt Ltd
01.2020 - 07.2022

Master’s - Health Informatics

Governors State University

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