Dr Arun Kumar

Dr Arun Kumar

  • Interest Area: Medical Statistics, Real World Evidence, Clinical Trials
  • Senior Fellow: Institute of Health Economics Epidemiology and Translational Sciences (IHEETS)
  • info@iheets.co.in
Institute of Health Economics Epidemiology and Translational Sciences (IHEETS)

New Delhi

Profile Summary

I have more than twenty years of experience in medical research with sound knowledge in statistical methodology. My varied research experience includes hospital based research, epidemiological studies and drug discovery process, covering many disease areas. I teach Research Methodology and Biostatistics to Medical and para-Medical students. Provided statistical guidance to several research projects, including post graduate student's thesis. I have very good communication skills in explaining statistical concepts to medical and social scientists. I have experience in supervising and managing teams, by mentoring and grooming resources with different skills.

My involvement in research starts from providing statistical inputs to protocol development including sample size determination, continues with assisting in designing questioner (CRF), coding of the data, database design, statistical analysis and support for publication and conference presentation. I am well versed with recent statistical techniques and statistical software, R, Python, SAS & SPSS. I have thorough understanding of regulatory requirements, Ethics in clinical research and Good Clinical Practices (GCP). I have experience as regulatory biostatistician, played crucial role in protecting public health by analyzing data and providing statistical expertise to regulatory bodies like US-FDA, EMEA and CDSCO decisions on drugs, biologics, and medical devices. Performed independent statistical analyses of clinical trial data for new drug applications, design complex experiments, evaluated scientific data, and prepare statistical reports to ensure the safety and effectiveness of products before they reach the public.

My aim is to offer statistical solutions to real life problems, by providing excellent and accessible statistical consulting service to colleagues and clients, and am committed to quality in experimental design, data analysis, report writing, scientific publication and training programs.

Education

University of Madras, Chennai, India

Doctor of Philosophy (PhD): Biostatistics

Oct 2014

Title: "Causal Modeling of Treatment Effects using Propensity Scores"

Christian Medical College, Vellore, India

Master of Science (MSc): Biostatistics

Apr 1995

With first class honors

Experience

Bapuji Dental College and Hospital / Shridevi Institute of Medical Sciences

Visiting Faculty - Professor of Biostatistics

Dec 2010 – Present

Cloudnine Hospitals / 4baseCare / Ennature Biopharma

Consultant
  • Work independently on all phases of complex clinical trial projects
  • Provide end-to-end statistical support to clinical research
  • Seamless integration with medical writers, clinical operations, data management, programming and regulatory for all matters pertaining to statistics
  • Statistical Analysis using SAS, SPSS, R and Python
  • Review and provide input to SOPs, work instructions and standardization process
  • Effectively communicate regarding methodology, caveats and results to stakeholders
  • Provide statistical support to Publication and conference presentation
  • Teach – Research Methods, Biostatistics, Scientific Writing and Programming

GlaxoSmithKline (GSK), Bangalore, India

Manager, Biostatistics & Prog.

Oct 2009 – Jun 2010

Lambda Therapeutic Research, Ahmedabad, India

Senior Manager, Biostatistics & Prog.

July 2008 – Sep 2009

i3statprobe, Mumbai, India

Manager, Biostatistics & Prog.

Mar 2007 – July 2008

Indian Council Medical Research, India

Biostatistician

Feb 1997 – Feb 2007

Professional Memberships

  • Life member - Indian Society of Medical Statistics (ISMS)
  • Life member - International Indian Statistical Association (IISA)
  • Associate Life Member - Indian Academy of Geriatrics
  • Statisticians in the Pharmaceutical Industry (PSI)

Selected Publications

Over 30 peer-reviewed publications. Selected recent works include:

Kapoor D, Bhandare MS, Sharma A, Kalayarasan R, Karunakaran M, Balasubramanian SK, Pal A, Palankar N, Darshanik DS, Soni S, Biravely SR, Namachivayam A, Singh RK, Varshney V, Chaudhary A, Sikora S, Gupta R, Govil S, Rebala P, Pottakkat B, Ramesh H, Chaudhari VA, Shrikhande SV. Real-World Evidence of Porto-Mesenteric Vein Resections with Pancreatectomy and the Development of Predictive Clinical Nomograms for Postoperative Outcomes-An Analysis of 389 Cases: The "Porto-Mesenteric Vein Resection-Indian MulticentrE" (PRIME) Study. Ann Surg Oncol. 2025 Oct;32(10):7410-7421. doi: 10.1245/s10434-025-17702-1. Epub 2025 Jul 5. PMID: 40616760; PMCID: PMC12454574.

Ann Surg Oncol. 2025 Jul 5.

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Jois SM, Rangalakshmi S, Iyengar SMJ, Mahesh C, Devi LD, Namachivayam AK. Artificial intelligence enhanced Chatbot boom: A single center observational study to evaluate assistance in clinical anesthesiology. J Anaesthesiol Clin Pharmacol. 2025 Apr-Jun;41(2):351-356. doi: 10.4103/joacp.joacp_151_24. Epub 2025 Mar 24. PMID: 40248774; PMCID: PMC12002681.

J Anaesthesiol Clin Pharmacol. 2025 Apr-Jun;41(2):351-356.

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Sp S, C RK, Kr A, Y R, N AK, Fernandez AM, Ahuja V. Delay in Time to Adjuvant Chemotherapy and its Impact on Oncological Outcomes in Patients Undergoing Optimal Cytoreductive Surgery for Advanced Ovarian Cancer: Analysis of 1480 Cases From the Indian HIPEC Registry. J Surg Oncol. 2024 Nov;130(6):1358-1363. doi: 10.1002/jso.27896. Epub 2024 Sep 30. PMID: 39348465.

J Surg Oncol. 2024 Nov;130(6):1358-1363.

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Singh A, Bhat V, Sudhakar S, Namachivayam A, Gangadharan C, Pulchan C, Sigamani A. Multicentric study to evaluate the effectiveness of Thermalytix as compared with standard screening modalities in subjects who show possible symptoms of suspected breast cancer. BMJ Open. 2021 Oct 19;11(10):e052098. doi: 10.1136/bmjopen-2021-052098. PMID: 34667011; PMCID: PMC8527152.

BMJ Open. 2021 Oct 19;11(10):e052098.

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