Summary
Overview
Work History
Education
Skills
Publications
Workshops And Seminars
Timeline
Generic

Dhruv D. Trivedi

Ahmedabad

Summary

Principal Biostatistician | Clinical Trial Expert | Team Leader

Biostatistician with over 12 years of experience in designing, analyzing, and interpreting data for a wide range of clinical trials (Phases I–IV), bioequivalence/bioavailability (BE/BA) studies, and healthcare research. Proven expertise across diverse therapeutic areas, including neurology, oncology, dermatology, respiratory, cardiology, rheumatoid arthritis, ulcerative colitis, and observational/registry studies.

Strong leadership background with experience managing and mentoring teams of biostatisticians, ensuring quality deliverables through peer reviews, and oversight of departmental initiatives. Skilled in applying advanced statistical methodologies and regulatory-compliant processes to support protocol development, statistical analysis plans (SAPs), and clinical study reports (CSRs).

Technical Proficiencies:

  • Statistical Software: SAS, R, Phoenix/WinNonlin, SPSS, JMP.
  • SAS Procedures: PROC PLAN, MEANS, UNIVARIATE, FREQ, NPAR1WAY, TTEST, CORR, GLM, MIXED, MI, MIANALYZE, LIFETEST, SGPLOT, SGPANEL.
  • Study Types: PK/BE studies, instrumental trials, real-world evidence (RWE), and observational studies.

Overview

12
12
years of professional experience

Work History

Principal Bio-Statistician

Syneos Health
Ahmedabad
09.2022 - Current
  • Acting as client POC for all the projects and related activities
  • Managing & Leading multiple studies throughout the study tenure
  • Planning Man Hours/Resource for Statistical Activity of Projects for self and team mates.
  • Facing and Presenting in Bid defence meeting & Vendor audits as Bio-stats representative
  • Handling sponsor/regulatory audit related to specific project or system
  • Senior Reviewer and providing inputs for all statistical Activities like:
  • Randomization, eCRF, Sample size, Protocol inputs & review
  • SAP Review, Review of source data, Tables & Listings, Figures
  • SAR & CSR inputs & review
  • Planning training program/material for new members in Team
  • Interacting with the other departments (CDM, Project Management, CT operations, Medical Writer/Medical Monitors, Report compilation, QA).

Senior Bio-Statistician

Syneos Health
Ahmedabad
05.2021 - 07.2022
  • Acting as client POC for all the assigned projects and related activities
  • Reviewing or providing overall Man Hours calculations or COs for Statistical Activity of Projects
  • Senior Review and providing inputs for all statistical Activities like:
  • Randomization, eCRF, Sample size, Protocol inputs & review
  • ADaM Specification Review, SAP & Shell Review, Review of source data, Tables, Listings, Figures
  • SAR & CSR inputs & review
  • Interacting with the internal and external stake or sponsor POCs from respective departments (CDM, Project Management, CT operations, Medical Writer/Medical Monitors, Report compilation, QA).

Senior Bio-Statistician

Cliantha Research (Karmic LifeSciences LLP)
Ahmedabad
06.2019 - 05.2021
  • Acting as client POC for all the projects and related activities
  • Managing & Leading Team of Biostatisticians (8+ Junior to Mid-level)
  • Providing Man Hours/Quotation for Statistical Activity of Projects
  • Part of Harmonization team of Global Compliance Cell at Cliantha for Process Development
  • SOP Development & Review
  • Responding to Regulatory queries
  • Handling sponsor audit related to specific project or system
  • Senior Reviewer and providing inputs for all statistical Activities like:
  • Randomization, eCRF, Sample size, Protocol inputs & review
  • SAP Review, Review of source data, Tables & Listings, Figures
  • SAR & CSR inputs & review
  • Planning training program for new members in Team
  • Interacting with the other departments (CDM, Project Management, CT operations, Medical Writer/Medical Monitors, Report compilation, QA).

Bio-Statistician Level 3

Cytel Statistical Software and Services Pvt. Ltd.
Ahmedabad
04.2018 - 06.2019
  • Performing Statistical Analyses of Healthcare studies using SAS and R.
  • Development/Validation of Tables/Listings/Graphs using SAS software.
  • Interpretation of the results based on graphs and tables.
  • Involved in generation of randomization using SAS and excel.
  • Develop and maintain SAS programs as per the demand of statistical analyses.
  • Interact within team and with other teams, such as CDM, Statistical Programming and Project Management, to ensure a high level of client satisfaction through successful execution of projects.
  • Presenting and discussing statistical analyses, related criteria and data issues in Kick-off meeting of individual projects.

Senior Technical Associate (Bio-statistician)

Lambda Therapeutic Research Ltd.
Ahmedabad
06.2013 - 03.2018
  • Statistical inputs in terms of analyses of various clinical trials and SAP preparation
  • Review of tables, listings & e-CRF of clinical trials as well as patient PK studies
  • Statistical Analyses of clinical trials using SAS Software.
  • Interpret the results with graphs and tables
  • Design protocol and reports of clinical trials and BA-BE studies for different regulatory
  • Calculation of sample size of specific study designs and its endpoint requirement for Clinical Trials/ BA-BE Studies.
  • Generation of randomization using SAS software
  • Analysis of in-vitro data (kinetic and equilibrium binding studies)
  • Develop and maintain statistical programs as necessary to perform analyses
  • Preparing standard operating procedures related to statistical methodology and requirements
  • Interact with other departments, such as Clinical Operations and Project Management, to ensure a high level of client satisfaction through successful execution of projects.
  • Respond to QA, Sponsor & Regulatory queries related to Statistics.

Education

Master of Philosophy - Statistics

School of Sciences, Gujarat University
Gujarat, India
01.2016

Master of Science - Statistics

School of Sciences, Gujarat University
Gujarat, India
01.2013

Bachelor of Science - Statistics

K.K.S.J Maninagar Science College.
Gujarat, India
01.2011

Skills

  • SAS software (Base Advanced)
  • SAS EG
  • R
  • SPSS
  • Phoenix/WinNonlin
  • JMP (graph builder)
  • Microsoft Office

Publications

Estimation of stature and Sex Determination from the Foot and/or Shoe Dimension in Youngsters of Ahmedabad city of India, Indian Journal of Forensic Medicine & Toxicology, 151‑156, 10, 1, 01/01/16

Workshops And Seminars

  • R-Programming, PHARMA-STATS, 05/01/21, 15-Days virtual training program
  • APPLICATIONS OF STATISTICS IN CLINICAL RESEARCH & LIFE SCIENCE INDUSTRY, Department of Statistics, School of Science, Gujarat University, Ahmedabad, Gujarat, India, 09/08/18, Part of organizing team
  • Basics of R-Software, CliPLab at Cytel Statistical Software and Services Pvt. Ltd., online training program
  • Define.XML, SientiaBio (Member of CDISC), Mumbai, Maharashtra, India, one day workshop
  • Pharmaceutical Statistics, PHARMA-STATS, Ahmedabad, Gujarat, India, course
  • INTRODUCTION TO PASW STATISTICS-18, statistics department Of M.G.Science institute, 20 session training program, DBT STAR COLLEGE SCHEME
  • Scope English Exam, office of Commissioner higher education, 2011, Passed
  • Applied mathematics & Statistics, statistics department of Statistics & Mathematics, Gujarat University, Ahmedabad, Gujarat, India, International Conference

Timeline

Principal Bio-Statistician

Syneos Health
09.2022 - Current

Senior Bio-Statistician

Syneos Health
05.2021 - 07.2022

Senior Bio-Statistician

Cliantha Research (Karmic LifeSciences LLP)
06.2019 - 05.2021

Bio-Statistician Level 3

Cytel Statistical Software and Services Pvt. Ltd.
04.2018 - 06.2019

Senior Technical Associate (Bio-statistician)

Lambda Therapeutic Research Ltd.
06.2013 - 03.2018

Master of Philosophy - Statistics

School of Sciences, Gujarat University

Master of Science - Statistics

School of Sciences, Gujarat University

Bachelor of Science - Statistics

K.K.S.J Maninagar Science College.

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Dhruv D. Trivedi