MAHESH
DIVAKARAN
Close to a decade of experience in clinical data analysis, CDISC standards, and statistical programming. Currently at IQVIA & pursuing a PhD in Statistics at Amity University. Based in Trivandrum, Kerala, India.
Hi, I'm Mahesh!
I'm a data scientist and statistical programmer with close to a decade of experience at the intersection of statistics, software engineering, and clinical research. I build R packages, automate clinical pipelines (SDTM, ADaM, TFL), develop interactive R Shiny dashboards, and have presented my research at international PHUSE conferences in the US and EU.
I'm currently a Senior Statistical Programmer at IQVIA and a PhD candidate in Statistics at Amity University. I'm also a volunteer with the CDISC Open-Source Alliance (COSA) and a life member of the Indian Society for Probability and Statistics.
My Tech Stack
R (Advanced) Python (Advanced) SAS Base SAS Macros SAS/STAT R Package Development R Shiny R Markdown
CDISC Standards SDTM ADaM TLG / TFL Define.xml FDA XML Submissions CSR & SAP Automation
admiral sdtm.oak xportr metacore rtables
Tableau Power BI ggplot2 Plotly Survival Analysis NLP / NER Git / GitHub
My Experience
- Lead R package development and validation for clinical trial reporting workflows
- Drive TLG generation using validated R packages aligned with CDISC and regulatory standards
- Maintain and expand an R package catalogue for reproducibility and compliance
- Led R Shiny dashboard development for clinical data visualization and TFL automation
- Architected R packages for end-to-end SDTM, ADaM, and TFL creation
- Mentored analysts in open-source clinical reporting tools
- Taught Biostatistics to medical students covering descriptive statistics, inferential methods, and clinical trial design
- Converted datasets to CDISC/SDTM standards across multiple therapeutic areas
- Developed SAS macro programs for ADaM dataset generation and TFL creation
- Generated XML outputs for FDA regulatory submissions
- Developed Bio-NER models, ML models for CLTV, pricing intelligence, and sales forecasting
- Built NLP-based sentiment analysis and chatbot systems
Publications & Papers
Let's work together.
Open to collaborations, research discussions, and consulting opportunities.
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