Tamilselvi Senthilkumar

About Tamilselvi Senthilkumar

Has been involved in standardization to the CDISC SDTM by creating the SDTM design specifications, including the Annotated CRF for more than 75 studies based on the SDTM v3.1 & V3.2 standards.• Has created Trial Design Domains for more than 20 Studies and had good knowledge on Protocol Standards.• Review the converted domains based on the compliance check using WebSDM rules and open CDISC Validator. • Has been involved in creating the metadata information of the study and based on the created metadata information, generated Define XML and also prepared the study specific data guide.• Communicate with clients on all project-related issues and queries.• Has worked with multiple CROs in specification preparation for Listings, Tables (as per SAP), TLFs Generation and delivering the TLFs (as per the SAP)• Specialties include building Data Analysis, Derived Dataset creation (as per ADAM) • Familiar with Clinical Trial Protocols, Study Reports as well as GCP and ICH Guidelines• Validation of macros, Reporting (Listing & Tables) and CDISC SDTM application development to convert the legacy protocol to SDTM v3.1 & V3.2 standard.• Provide primary support for study standardization to the CDISC SDTM by creating the SDTM design specifications, including the Annotated CRF, programming, Mapping Specification, Programming, trial design domains, create data definition files, Data giude and generate Define XML.• Perform as a team leader for the CDISC team including planning and executing meetings.• Involved in ADaM mapping specification based on the SDTM data.• Understand the Client specific standards and has been involved in the standardization of the data based on the client specific standards.• Developed Listings & Tables for Blinded, Unblinded and DMC for current ongoing study • Designed Database for the Database and involved in Data Capture, Data Validation, Data Extraction, Analysis and Development of Listing, Table and Graphs

Experience

1. Principal Statistical Programmer

   Cytel

   Sep 2024 — Present · Pune, IN

Education

• Bharathiyar University

  Bachelor of Engineering (BE), Computer Science

• Kongu Engineering College

  Bachelor of Engineering (B.E.), Computer Science

  2001 — 2004

Skills

• 21 Cfr Part 11
• Oncology
• Validation
• Sas
• Clinical Trials
• Statistical Programming
• Meddra
• Business Analysis
• Gcp
• Tdm
• Define Xml
• Sdlc
• Adam
• Sdtm
• Cdisc