Pradeep Vardhan

About Pradeep Vardhan

I••••••••@gmail.com About:I’m Pradeep, a Statistical Programmer II at Syneos Health, with over 3+ years of experience in statistical programming and clinical data analysis. I previously worked at Dr. Reddy’s Laboratories, contributing to oncology clinical studies across multiple phases (I to specialize in SAS, R, and SQL, with a strong focus on eSubmissions, CDISC standards (SDTM/ADaM), and the development of high-quality Tables, Listings, and Graphs (TLGs) for regulatory reporting. My work supports patient centric outcomes and ensures compliance with global regulatory standards.Technical Skillset: Programming Languages & Tools Proficient in SAS (Base, Advanced, Macros, SQL). Skilled in R programming with experience using dplyr, tidyr, plotly, shiny, Caret, and Admiral packages.Experienced in MySQL for handling clinical databases. CDISC StandardsWell-versed in SDTM (Study Data Tabulation Model).Experienced in ADaM (Analysis Data Model) implementation.Skilled in generating and validating SDTM & ADaM XPT files.Familiar with Define.XML, cSDRG (Clinical Study Data Reviewer’s Guide), ADRG (Analysis Data Reviewer’s Guide), and aCRF (annotated CRF) reviews.Knowledgeable about eCTD (electronic Common Technical Document) standards.Clinical Reporting:Proficient in TLG (Tables, Listings, Graphs) generation using SAS.Experienced in using SAS ODS for output in RTF, Word, and other formats.Familiar with graphical procedures such as PROC GChart, GPlot, and ANOVA.Clinical Phases Experience:Hands on experience in clinical Phases I, II, and Areas Worked On: Oncology (eSub and OSI BIMO studies).Neurology (OSI BIMO studies).PK/PD studies.Food effect studies.Platforms: Proficient in Pinnacle 21 Enterprise (P21E) & Pinnacle 21 Community (P21C) for data validation.Skilled in using RStudio and RShiny for data visualization and interactive dashboards.Experience with SAS Studio and SAS Enterprise Guide.Familiar with version control and collaboration tools like Git, GitHub, GitLab, and Jira. Certifications: Base SAS Certified Programmer (SAS 9.4)Professional Traits:I’m known for being enthusiastic, versatile, Determinant and goal-driven, consistently delivering high-quality outputs that support regulatory submissions, drug development, and ultimately, improve patient outcomes.

Experience

1. Statistical Programmer Ii (Esub & Osi)

   Syneos Health

   Dec 2024 — Present · 4th building Raheja mind space Hyderabad, IN

   FDA, EMA, PMDA, NMPA etc,Working on eSubmission and OSI BIMO deliverables.Performed rigorous reviews of SDTM datasets and Define.xml, ensuring alignment with global regulatory submission standards (FDA, NMPA, PMDA).Utilized advanced QC checklists to address technical rejection criteria specified by major health authorities, proactively identifying and remediating potential issues before regulatory submission.Reviewed comprehensive ADaM Clinical Review Tool (CRT) packages, including datasets, Define.xml, and Analysis Data Reviewer’s Guide (ADRG), guaranteeing conformance with CDISC and agency expectations.Drove the application of technical rejection criteria and sponsor QC workflows to optimize data quality and approval readiness.Executed meticulous quality control on ADaM programming deliverables verifying dataset-program traceability, derivation logic, and adherence to analysis plans.Maintained strict consistency with technical guidance from FDA, NMPA, and PMDA: closely monitored evolving standards and validation requirements.Supported the Office of Scientific Investigation (OSI) through timely generation of BIMO (Bioresearch Monitoring) listings for both safety and efficacy submissions.Led the development and validation of BIMO datasets/listings in accordance with FDA protocols.Leveraged expertise in SAS and R programming for complex data manipulation, analytics, and regulatory reporting.Utilized modern version control tools (VS Code, GitLab) for collaborative development, efficient workflow management, and robust data integrity controls.Ensured end-to-end data quality, traceability, and consistency across multi study submission packages.Collaborated with multidisciplinary teams to support inspection readiness, answer regulatory queries, and sustain compliance during global eSubmission projects.

Education

• Sri Sathya Sai Institute of Higher Learning

  Board of Intermediate Education Andhra Pradesh (12th - Grade), Bi.P.C (Biology)

• Sri Chaitanya College of Education

  Personal goal pursuit, Biology, General

• Dr.K.V.Subba Reddy Institute of Technology, Kurnool

  B pharmacy (Affiliated by JNTU Anantapur), Pharmaceutical Sciences

• Zilla Parishad High School

  10th class (SSC), Natural Sciences