Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Komali Mathi

Austin,TX

Summary

Highly-educated SAS(Statistical Analysis Software) Clinical Programmer with commitment to excellence and more than 2 years of experience. Involved in programming Integrated Summary of Safety(ISS). Extensive experience in working with Phase I-III trials, creating and validating Define.XML, SDTM, ADaM, TLF, using ODS, annotating CRF/table shell and specification building for SDTM and ADaM. Extensive understanding of Clinical Data, Trial Design, SAP, CRF, study protocol and management of clinical programmers. Logical and professional with excellent problem-solving skills.

Overview

3
3
years of professional experience
1
1
Certification

Work History

Data Analyst Intern

Vensa Tek LLC
01.2024 - Current
  • Collecting, cleaning, and analyzing large datasets to extract meaningful insights and support decision-making processes.
  • Developing and implementing statistical models and algorithms to solve specific business problems.
  • Designing and maintaining dashboards and reports to visualize data and communicate key findings to stakeholders.
  • Collaborating with cross-functional teams to identify opportunities for data-driven improvements in business processes and strategies.
  • Conducting ad-hoc analysis and presenting findings in clear and concise manner to non-technical audiences.
  • Ensuring data accuracy, integrity, and security by following best practices and guidelines.
  • Staying updated with latest trends and technologies in data analytics and applying them to improve data analysis processes.
  • Contributing to development and implementation of data governance policies and procedures.
  • Working on special projects and initiatives as assigned by management, demonstrating flexibility and adaptability in fast-paced environment.
  • Optimized SQL queries for faster processing times, increasing overall productivity within the team.

Sr. Clinical SAS Programmer

.
01.2021 - 06.2022
  • Participate in projects dealing with assessment, design and/or implementation of data standards (e.g., CDISC SDTM and CDASH).
  • Perform Gap Analysis on studies requiring migration to CDISC standards to ensure all documentation and datasets necessary to perform migration activities are present and without issue. Work with migration team and client to resolve any issues.
  • Annotate case report forms (CRFs) according to CDISC Implementation Guideline for migration to SDTM.
  • Create SDTM specifications document based on CDISC Implementation Guideline.
  • Follow standardized SDTM migration programming procedures to create quality Standard Data Tabulation Model (SDTM) compliant SAS datasets and Define.XML documents
  • Create analysis datasets (e.g., ADAM) specifications based on Statistical Analysis Plan (SAP) or any study analysis algorithm.
  • Convert analysis datasets specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs.
  • Analyze SAS code to find causes of errors and revise programs.
  • Write and maintain documentation of changes to SAS code, programs, and specifications.
  • Revise programs for corrections, enhancements, or system environment changes.
  • Coordinate with other programmers about program revisions.
  • QC SAS programs for Dataset, Tables, Listings, and Figures following departmental QC procedures.
  • Create Define XML, Define PDFs, and Reviewers Guides.
  • Apply CDISC knowledge (SDTM and ADaM) standards to dataset programming.
  • Follow established standardized design and programming procedures (CDISC).
  • Assist in establishing standardized programming procedures and work instructions; develop, enhance, evaluate, and validate standardized macros and utility programs; ensure that regulatory requirements are met through validation/compliance activities.
  • Create statistical analysis outputs to be used in support of final reports, abstracts, posters, manuscripts, and other clinical publications; support systems to produce electronic regulatory submissions.
  • Prepared variety of different written communications, reports and documents to ensure smooth operations
  • Validated SDTM/ADaM using Pinnacle 21
  • Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork
  • Utilized both agile and waterfall methodologies to develop software of varying complexity and business needs.

Education

Master of Science - Health Information Technology

Governors State University
Park Forest, IL
05.2024

Bachelor of Science - Bachelor of Dental Surgery

YSRUHS
Andhra Pradesh, INDIA
02.2021

Skills

  • ISS
  • Production of SDTM/ADaM/TLF
  • QC of SDTM/ADaM/TLF
  • Structured Query Language
  • ODS
  • Macro Programming
  • R Programming

Certification

  • SAS Certified Clinical Trials Programmer Using SAS 9

Timeline

Data Analyst Intern

Vensa Tek LLC
01.2024 - Current

Sr. Clinical SAS Programmer

.
01.2021 - 06.2022

Master of Science - Health Information Technology

Governors State University

Bachelor of Science - Bachelor of Dental Surgery

YSRUHS

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Komali Mathi