MAHESH
DIVAKARAN
Hi, I'm Mahesh!
I'm a Senior Statistical Programmer and Clinical Data Scientist with close to a decade of experience in clinical data analysis, CDISC standards (SDTM, ADaM), and TLG/TFL generation. I currently work at IQVIA and am pursuing my PhD in Statistics at Amity University, Lucknow.
My work sits at the intersection of statistics, software engineering, and clinical research. I have presented original research at PHUSE US Connect 2023 and PHUSE EU Connect 2021 & 2022, authored peer-reviewed conference proceedings, and built R packages used in production clinical reporting pipelines.
Outside work, I volunteer with the CDISC Open-Source Alliance (COSA) and the Kerala Police Cyberdome. I'm a life member of the Indian Society for Probability and Statistics (ISPS) and hold an NCC B Certificate.
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 LaTeX
Experience
- Lead R package development and validation for clinical trial reporting
- Maintain R package catalogue for reproducibility and compliance
- Drive TLG generation aligned with CDISC and regulatory standards
- Led R Shiny dashboard development and TFL reporting automation
- Architected R packages for end-to-end SDTM / ADaM / TFL creation
- Mentored analysts in open-source clinical reporting tools
- Taught Biostatistics covering descriptive statistics, inferential methods, and clinical trial design
- Converted clinical study datasets to CDISC/SDTM standards across multiple therapeutic areas
- Developed SAS macro programs for ADaM and TFL generation
- Generated XML outputs for FDA regulatory submissions
- Developed Medical Entity Recognition (Bio-NER) models for insurance data
- Researched cryptocurrency value forecasting using time-series models
- Developed ML models for Pricing Intelligence, Sales Forecasting, and CLTV
- Delivered a webinar on the Buy Till You Die model for CLTV
- Tweet Sentiment Analysis using NLP, contributed to chatbot development
- Built regression, classification, and dynamic pricing models
Education
Let's collaborate.
Open to consulting, research, and speaking opportunities.
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