Summary
Overview
Work History
Education
Skills
Certification
Awards
Professional Presentations & Knowledge Sharing
SDTM EXPERTISE:
ADaM Expertise:
Reporting (TLF) Programming:
Therapeutic Area Experience:
Timeline
Generic

Paranthaman Muralithararam

Senior Biostatistical Programmer
Vellore

Summary

Certified Base SAS Programmer with over 7 years of experience in the Clinical Research Organization (CRO) sector, specializing in Statistical Programming and Clinical Data Management (CDM). Expertise includes interpreting study protocols, Statistical Analysis Plans (SAPs), and shells to produce CDISC-compliant datasets (SDTM, ADaM) and TLF reports focused on safety and efficacy. Proficient in developing and optimizing complex SAS programs and macros to standardize datasets according to study requirements, while collaborating effectively with cross-functional teams to manage project meetings and support resource planning. Demonstrated leadership as a Lead/Co-Lead programmer across multiple studies, with a proven ability to mentor and train associate programmers. Strong skills in Python, R, and SQL enhance analytical problem-solving capabilities.

Overview

6
6
years of professional experience
3
3
Certifications

Work History

SENIOR BIOSTATISTICAL PROGRAMMER

Premier Research
10.2023 - Current
  • Work on Various therapeutic areas such Neurology, Oncology, Psychiatry and NIH studies for statistical programming as well as DM SAS programming activities
  • Creating Datasets as per CDISC Data Standard (SDTM, ADAM & TLF)
  • Develop EPOCH & VISIT macros as study specific and addressing Pinnacle reports for all SDTM domains for each deliverable
  • Work as a Lead/Co-lead programmer in multiple studies, working closely with Lead Biostatistician to draft the SDTM, ADAM specification & TLF shell updates as per Study requirement
  • Having sound experience in reviewing Lab and Questionnaire External Vendor datasets
  • Managing and mentoring Associate Programmers to deliver the Data Transfer in timely manner.

SENIOR BIOSTATISTICAL PROGRAMMER

Premier Research
03.2023 - 10.2023
  • Delivered statistical programming and Data Management SAS programming across therapeutic areas, including Dermatology, Analgesia, Anxiety Disorders, Chronic Plaque Psoriasis, Oncology, and Psychiatry.
  • Developed CDISC-compliant datasets (SDTM, ADaM) and TLF outputs to support clinical and regulatory deliverables.
  • Designed study-specific macros (EPOCH, VISIT) and generated Pinnacle reports across all SDTM domains.
  • Actively contributed to regulatory submissions, including ISS, ISE, DSUR, and Interim Analyses.
  • Collaborated with Study Leads and Lead Biostatisticians to draft SDTM/ADaM specifications and update TLF shells in line with study protocols and submission standards.

BIO STATISTICAL PROGRAMMER

Premier Research
05.2022 - 03.2023
  • Contributed to statistical programming across diverse therapeutic areas, including Analgesia, Anxiety Disorders, Psoriasis, Oncology, and Psychiatry.
  • Developed CDISC-compliant datasets (SDTM, ADaM) and TLF outputs.
  • Supported regulatory submissions such as ISS, DSUR, and Interim Analyses.
  • Collaborated with Programming Leads and Biostatisticians on SDTM/ADaM specifications and TLF shell updates per study requirements.

CLINICAL SAS PROGRAMMER II

Symbiance Pharma Solutions
08.2021 - 04.2022
  • Worked on Neurology Therapeutic area study (Phase II open Label) for statistical programming activities
  • As per Study Protocol, SAP & Shell, updated the specification & working closely with senior peers to provide CDISC Standard Datasets
  • Created CDISC datasets (SDTM, ADAM & TLF) with help of Base SAS, Proc SQL & SAS Macros
  • Involved in knowledge sharing sessions and mentoring junior resources to the team
  • Worked in Clinical data listing reports such as DM listings, Reconciliation for various vendor data files, Missing Pages & Protocol deviation listings

CDM PROGRAMMER I

Pharmaceutical Product Development, PPD
05.2021 - 08.2021
  • As per Specifications provided by DM team, developed Complex SAS codes with good quality for various kinds of Clinical Data Listing reports and assisted them to draft & update Specification as regards to Sponsor requirement
  • Handled multiple priority programming development activities as regards to Sponsors requirements without supervision

ASSOCIATE CLINICAL DATA PROGRAMMER

ICON PLC
12.2019 - 05.2021
  • Involved in Import Data Conversion activity that converting various input format files into SAS datasets
  • Assisted CDL's, CDCs to update the specification of SAE, Central-Lab Reconciliation to modify specifications as per sponsor's need
  • Developed SAS programs for missing pages, missing visits, Clean Patient Tracker & Protocol Deviation listing reports from scratch for multiple sponsors
  • Worked in multiple Clinical Data Listing reports with little guidance of programming leads.

INTERN AS A (SAS) DATA ANALYST

DUN & BRADSTREET Technologies Data Services
06.2019 - 11.2019
  • Involved in a project for Investigational Reports Team
  • Identified potential lending liabilities and credit risks in lending by analyzing financial data
  • Performed initial and follow-up customer credit reviews after evaluation of their financial data
  • Consistently analyzed existing customer's financial data to determine if established credit limits are appropriate
  • Collecting the Credit reports of the companies
  • In credit reports, Analyzing the business information, Executive summary, Business History, Business Registration, Government Activity Summary, Financial Statements, Public Filings, Commercial Credit score, Financial stress score, Viability Ratings
  • Worked on main investigational Reports like commercial Credit score, financial stress score, Viability rating.
  • Automated the Process for Investigational Reports using SAS, which has been approved and implemented.

Education

B.E - EEE

Meenakshi Sundararajan Engineering college
Chennai, Tamil Nadu
05.2018

HSC - undefined

Vetri Vikaas Boys Higher Secondary School
Salem, Tamil Nadu
06.2014

SSLC - undefined

Sri Krishna Mat HS school
Arakkonam, Tamil Nadu
04.2012

Skills

  • SAS programming expertise
  • Fundamentals of RDMS

  • Python
  • R programming proficiency

Certification

BASE SAS GLOBAL CERTIFICATION

Awards

ICON PLC, Chennai, India [12/2019 to 05/2021]:

  • Recognized twice as “Star Performer” for outstanding contributions and performance excellence.
  • Honored with the “ICON Inspire Award” for exceptional achievement and dedication.

Professional Presentations & Knowledge Sharing

  • Collaborating Multiple Graphs” – Presented to the Global Biostatistics Department, Premier Research (2023-10).
  • Customizing SAS Plots A Beginner’s Guide to DATTRMAP and SGANO” – Delivered presentation to the Global Biostatistics Department, Premier Research (2023-03).
  • Application of AI/ML and NLP in Clinical Trials” – Presented at PHUSE-India Single-day event, Pfizer, Chennai (2022-12).

SDTM EXPERTISE:

  • Extensive experience in writing specification and programming across multiple SDTM domains.
  • Trial Domains and Special Purpose Domains
  • Interventions: EX, EC, CM, and PR.
  • Events: AE, MH, DS, VE and DV.
  • Findings: LB, QS, NV, FT, IE, MB, SC, DA, EG, VS, PC and PE.
  • Developed EPOCH and VISIT macro as study specific.

ADaM Expertise:

  • Extensive experience in programming and specification writing for safety and efficacy ADaM domains.
  • ADSL, ADCM, ADAE, ADLB, ADVS, ADEFF, ADQS and ADMI.

Reporting (TLF) Programming:

  • Tables: Developed Demographics, Disposition, Adverse Events, Concomitant Medications, Laboratory Summaries/Shift Tables, and Efficacy Tables utilizing advanced SAS procedures (PROC ANCOVA, PROC GLM, PROC RANK, PROC UNIVARIATE for residual analysis, PROC NPAR1WAY for Hodges–Lehmann Estimator, and PROC MIXED).
  • Extensive experience in developing efficacy tables within Alzheimer’s and Neurology therapeutic areas.
  • Listings: Development of medium-to-complex level listings
  • Figures: Creation of spaghetti plots, survival plots, and compilation of study-specific figure reports.

Therapeutic Area Experience:

  • Neurology (Co-Lead Programmer) – Co-led all programming activities, including SDTM, ADaM, and TLF development, and managed eSUB package preparation and delivery.
  • Psychiatry (Key Team Member) – Actively involved in all programming activities across SDTM, ADaM, and TLF outputs, contributing to high-quality eSUB submissions.
  • Alzheimer’s Disease (Lead Programmer) – Directed all programming tasks for SDTM, ADaM, and TLF development; oversaw preparation and submission of eSUB packages.
  • Oncology (Key Team Member) – Participated in all programming activities, providing expertise in updating and enhancing ADaM datasets and TLFs.
  • Dermatology (Co-Lead Programmer) – Oversaw and contributed to all SDTM programming activities, supporting eSUB package submissions in compliance with regulatory standards.

Timeline

SENIOR BIOSTATISTICAL PROGRAMMER

Premier Research
10.2023 - Current

SENIOR BIOSTATISTICAL PROGRAMMER

Premier Research
03.2023 - 10.2023

BIO STATISTICAL PROGRAMMER

Premier Research
05.2022 - 03.2023

CLINICAL SAS PROGRAMMER II

Symbiance Pharma Solutions
08.2021 - 04.2022

CDM PROGRAMMER I

Pharmaceutical Product Development, PPD
05.2021 - 08.2021

ASSOCIATE CLINICAL DATA PROGRAMMER

ICON PLC
12.2019 - 05.2021

INTERN AS A (SAS) DATA ANALYST

DUN & BRADSTREET Technologies Data Services
06.2019 - 11.2019

HSC - undefined

Vetri Vikaas Boys Higher Secondary School

SSLC - undefined

Sri Krishna Mat HS school

B.E - EEE

Meenakshi Sundararajan Engineering college
Paranthaman MuralithararamSenior Biostatistical Programmer