Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 30 /hr

★★★★★

☆☆☆☆☆

Hire Sharada M.

United States

USD 30 /hr

Freelance Clinical SAS Programmer | Expert in SAS, R | 5+ yrs in Pharma & CRO |CDISC, SDTM, ADaM, Data Validation

Profile Summary

As a Clinical SAS Programmer, I specialize in developing and validating SDTM datasets, creating documentation such as specifications, aCRFs, and define.xml. I use SAS 9.4 and Pinnacle 21 Enterprise for data validation and edit checks, ensuring CDISC compliance. My work includes integrating third-party vendor data with eCRF data and identifying discrepancies through data cleaning listings. I review protocols, SAPs, and dataset specifications, managing deliverables, issue logs, and training logs for transparency. I have received training in clinical reporting using R, including ADaM transformations with Pharmaverse R packages and creating TLGs with NEST. My training also covers compliance with ICH GCP, FDA regulations, and Good Documentation Practices (GDP). Additionally, I have gained expertise in clinical trial operations, regulatory binder management (eTMF, CTMS), AE/SAE reporting, and protocol execution.

Subject Matter Expertise

• ☆ Data Analysis
• ☆ Data Management
• ☆ Data Manipulation
• ☆ Data Cleaning
• ☆ SAS
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Clinical Data Management
• ☆ Clinical Trials Data Analysis
• ☆ Regulatory Affairs

Services

• Data & AI

Data & AI Statistical Analysis, Data Mining, Data Cleaning, Data Processing

Work Experience

Senior Statistical Programmer

Pfizer

September 2021 - November 2022

Programmer

IQVIA

October 2019 - September 2021

SDTM Programmer

Accenture

March 2017 - October 2019

Education

M.Sc.

Bharati Vidyapeeth University

May 2013 - May 2015

B.Sc.

University of Pune

May 2010 - May 2013

Certifications

• Hands On Clinical Reporting Using R

  Genentech

  https://www.coursera.org/account/accomplishments/records/TCMN8T0VSSR4

  January 2025 - Present

• Clinical Research Professional Training and Education

  Clinical Research Fastrack

  https://api-v4.skyprepapp.com/public_api/view_certificate?course_progress_id=89226958&view_key=linkedin

  September 2024 - Present

• Certificate of ICH GCP E6 R (2) Completion

  Arizona State Board for Private Postsecondary Education

  https://api-v4.skyprepapp.com/public_api/view_certificate?course_progress_id=89226958&view_key=linkedin

  September 2024 - Present

• Introduction to Clinical Research: Clinical Trial Phases and Design

  UC Berkeley Extension

  May 2024 - January 2025

• Clinical Trial Planning: Protocol Development, Data Management and Clinical Site Activities

  UC Berkeley Extension

  January 2024 - February 2024