プロフィール詳細

プロジェクトを作成

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Sharada M.に依頼

United States

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

プロフィール概要

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.

専門分野

• ☆ 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

サービス

• Data & AI

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

職務経験

Senior Statistical Programmer

Pfizer

9月 2021 - 11月 2022

Programmer

IQVIA

10月 2019 - 9月 2021

SDTM Programmer

Accenture

3月 2017 - 10月 2019

学歴

M.Sc.

Bharati Vidyapeeth University

5月 2013 - 5月 2015

B.Sc.

University of Pune

5月 2010 - 5月 2013

認定資格

• Hands On Clinical Reporting Using R

  Genentech

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

  1月 2025 - 現在

• 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

  9月 2024 - 現在

• 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

  9月 2024 - 現在

• Introduction to Clinical Research: Clinical Trial Phases and Design

  UC Berkeley Extension

  5月 2024 - 1月 2025

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

  UC Berkeley Extension

  1月 2024 - 2月 2024