MAHESH
DIVAKARAN

Senior Statistical Programmer · Clinical Data Scientist · PhD Candidate

Professional Summary

Senior Statistical Programmer and Clinical Data Scientist with close to a decade (9+ years) of experience in clinical data analysis, CDISC standards (SDTM, ADaM), and TLG/TFL generation. Currently a PhD candidate in Statistics at Amity University. Expert in R, SAS, and Python with a strong track record of building R packages, automating clinical reporting pipelines, and developing R Shiny dashboards. International conference presenter (PHUSE US & EU), SAS Certified Base Programmer, and part-time Biostatistics lecturer. Experienced in FDA regulatory submissions and cross-functional team leadership.

Core Competencies
Statistical Programming
R (Advanced)Python (Advanced) SAS BaseSAS Macros SAS/STATR Package Dev R ShinyR Markdown
Clinical & Regulatory
CDISCSDTM ADaMTLG / TFL Define.xmlFDA XML Submissions CSR & SAP Automation
Pharmaverse
admiralsdtm.oak xportrmetacore rtables
Other Tools
TableauPower BI ggplot2Plotly Survival AnalysisNLP / NER Git / GitHubLaTeX
Professional Experience
Senior Statistical Programmer
IQVIA RDS Pvt. Ltd. · India
July 2024 – Present
  • Lead R package development and validation for clinical trial reporting workflows
  • Maintain and expand an R package catalogue ensuring reproducibility and compliance
  • Drive TLG generation using validated R packages aligned with CDISC and regulatory standards
Associate Lead – Clinical Data Analytics
Genpro Research Pvt. Ltd. · Trivandrum, Kerala
April 2023 – July 2024
  • Led R Shiny dashboard development for clinical data visualization and TFL automation
  • Architected and maintained R packages for end-to-end SDTM, ADaM, and TFL creation
  • Mentored and trained analysts in open-source clinical reporting tools
  • Developed SAS programs for clinical summaries in compliance with CDISC standards
Data Analyst Level II
Genpro Research Pvt. Ltd. · Trivandrum, Kerala
April 2022 – March 2023
  • Developed R Shiny dashboards for clinical data visualization and interactive trial reporting
  • Built R packages to automate ADaM dataset generation and SAS date conversion
  • Created R Markdown documentation and catalogues for R scripts
Statistical Programmer Level I
Genpro Research Pvt. Ltd. · Trivandrum, Kerala
September 2019 – March 2022
  • Converted clinical datasets to CDISC/SDTM across multiple therapeutic areas
  • Developed SAS macro programs for ADaM and TFL creation
  • Generated XML outputs for FDA regulatory submissions
  • Conducted COVID-19 data analysis using Lasso and Ridge Regression
Data Scientist
Menerva Software · Cochin, Kerala
February 2019 – November 2019
  • Developed Medical Entity Recognition (Bio-NER) models for insurance data
  • Researched cryptocurrency value forecasting using time-series models
Data Scientist / ML Developer
Suyati Technologies · Cochin, Kerala
June 2018 – January 2019
  • Developed ML models for Pricing Intelligence, Sales Forecasting, and CLTV prediction
  • Delivered a webinar on the Buy Till You Die model for CLTV
Business Analyst
BRIDGEi2i Analytics Solutions Pvt. Ltd. · Bangalore
May 2017 – May 2018
  • Tweet Sentiment Analysis using NLP; contributed to chatbot development (NLU)
  • Built regression, classification, and dynamic pricing models
Teaching Experience
Part-Time Lecturer in Biostatistics
Gulf Medical University · UAE (Remote)
January 2022 – August 2023
  • Taught Biostatistics to medical students covering descriptive statistics, inferential methods, clinical trial design, and data interpretation
Education
PhD in Statistics (In Progress)
Amity University · Lucknow, Uttar Pradesh
2024 – Present
Diploma in Project Management
Oxford Home Study Center (OHSC) · Oxford, UK
2023
M.Sc. in Statistics
Cochin University of Science and Technology · Kerala
2015 – 2017
B.Sc. in Statistics
Christian College, Kattakada · University of Kerala
2012 – 2015
Certifications
SAS Certified Base Programmer  ·  SAS Institute · 2021
IBM Data Science Professional Certification  ·  IBM · 2020
Data Science Specialization (R)  ·  Johns Hopkins University / Coursera · 2022
Google Data Analytics Professional Certification  ·  Google · 2023
Google Project Management Professional Certification  ·  Google · 2024
Career Essentials in Data Analysis  ·  Microsoft & LinkedIn · 2023
SDTM001: Introduction to Study Data Tabulation Model  ·  CDISC
Publications & Conference Proceedings
Automation of ADaM Dataset & TFL Visualization through an R Package – GenAdam2 Divakaran, M. & Mohanan, M. K. (2023). PHUSE US Connect 2023. Orlando, USA.
Automation of Standard ADaM Variables Through an R Package – GenAdam Divakaran, M. & Mohanan, M. K. (2022). PHUSE EU Connect 2022. Belfast, UK.
Clinical Design – Visualization and Analysis using R Shiny Divakaran, M. & Sudhakar, A. (2021). PHUSE EU Connect 2021. London, UK.
Comparison of some epidemiological models on COVID-19 spread in Kerala Ambika, A. P., Divakaran, M., Menon, N. & Das, U. (2020). DOI: 10.13140/RG.2.2.26715.39201
Conferences
Conference Location Year
PHUSE US Connect 2023 Orlando, USA March 2023
PHUSE EU Connect 2022 Belfast, UK November 2022
PHUSE EU Connect 2021 London, UK November 2021
PSI Conference 2021 Virtual October 2021
ISPS Conference 2016 Aligarh, India December 2016
Affiliations & Awards
Volunteer – CDISC Open-Source Alliance (COSA) Volunteer – Kerala Police Cyberdome Life Member – ISPS

🏆 Quarterly Employee Award – Genpro Research  ·  NCC B Certificate – NCC India