Sandeep Menon, PhD
Adjunct Assistant Professor
Boston University School of Public Health
Dept of Biostatistics

PhD, Boston University School of Public Health
MPH, Boston University School of Public Health

Dr. Sandeep Menon is currently an Executive Director and Head of Biostatistics at the Bio-therapeutics Research & Development at Pfizer Inc. and Adjunct Assistant Professor of Biostatistics at Boston University. He has been in the industry for over 11 years’ and has led submissions (NDA, PMA and BLA) with several interactions with the FDA (US Agency), EMEA (European Agency) and PMDA (Japanese Agency).

At Pfizer, he is in charge of all of the biostatistics activities for the entire portfolio in his unit spanning from discovery through Proof of concept studies. He is a member of the global biostatistics leadership team and is responsible to oversee all biostatistical aspects spanning 4 major research units in 1) Immunology and Auto-Immune Disease, 2) Inflammation and Remodeling, 3) Rare Diseases and 4) Center of Therapeutic Innovation. Before joining Pfizer, he held positions at Biogen idec, and Aptiv Solutions.

Sandeep has been teaching part-time since 9 years and has taught introductory, intermediate and advanced courses in biostatistics related to clinical trials. He is also a biostatistics faculty (Online) for International Society of Biopharmaceutical Sciences ( He is a regular invited speaker, panels and short course instructor in academic forums and FDA/Industry conferences.

His research interests are in adaptive designs and personalized medicine. He has publications in well-known journals and recently co-authored/ co-edited book titled “Clinical and Statistical Considerations in Personalized Medicine” (published in April’ 2014). He is currently co-editing/co-authoring books on” Classical, Adaptive and Bayesian Methods in Clinical trials using SAS”, “Clinical Trial Simulations”, “Confidence Intervals” and “Biosimilars”. He is the co-chair of cross Industry DIA-sponsored sub team under Adaptive Design Scientific Working Group on the “Role of Adaptive Designs in Personalized Medicine”, member of the sub-team “Biomarker identification and analysis” sponsored by the Society for Clinical trials and is in the Editorial Board for Journal of Medical Statistics and Informatics.

Sandeep received his Medical degree from University of Bangalore (formerly Karnataka University), India and later completed his Masters and PhD in Biostatistics at Boston University. He was a research fellow at Harvard Clinical Research Institute and has received several awards for academic and research excellence.

Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.

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  1. Wu J, Banerjee A, Jin B, Menon SM, Martin SW, Heatherington AC. Clinical dose-response for a broad set of biological products: A model-based meta-analysis. Stat Methods Med Res. 2018 09; 27(9):2694-2721. PMID: 28067121; DOI: 10.1177/0962280216684528;
  2. Damjanov N, Tlustochowicz M, Aelion J, Greenwald M, Diehl A, Bhattacharya I, Peeva E, Menon S, Gourley I. Safety and Efficacy of SBI-087, a Subcutaneous Agent for B Cell Depletion, in Patients with Active Rheumatoid Arthritis: Results from a Phase II Randomized, Double-blind, Placebo-controlled Study. J Rheumatol. 2016 Dec; 43(12):2094-2100. PMID: 27909139
  3. Laage T, Loewy J, Menon S, Miller E, Pulkstenis E, Kan-Dobrosky N, Coffey C. Ethical Considerations in Adaptive Design Clinical Trials. Therapeutic Innovation and Regulatory Science. 2016; 51(2). View Publication
  4. Wang J, Chang M, Menon S. Biomarker informed add-arm design for unimodal response. J Biopharm Stat. 2016; 26(4):694-711.View Related Profiles. PMID: 26010506; DOI: 10.1080/10543406.2015.1052474;
  5. Zou B, Jin B, Koch GG, Zhou H, Borst SE, Menon S, Shuster JJ. On model selections for repeated measurement data in clinical studies. Stat Med. 2015 May 10; 34(10):1621-33. PMID: 25645442; PMCID: PMC4390448; DOI: 10.1002/sim.6414;
  6. Wu J, Menon S, Chang M. An Adaptive Staggered Dose Design for a Normal Endpoint. J Biopharm Stat. 2015; 25(4):731-56.View Related Profiles. PMID: 24904986; DOI: 10.1080/10543406.2014.920862;
  7. Yansong Cheng, Surajit Ray, Mark Chang & Sandeep Menon. Statistical Monitoring of Clinical Trials With Multiple Co- Primary Endpoints Using Multivariate B-value. Statistics in Biopharmaceutical Research. 2014; 6(3):241-250.
  8. Mitchell B, Leone D, Feller K, Menon S, Bondzie P, Yang S, Park HY, Mahalingam M. Protein expression of the chemokine receptor CXCR4 and its ligand CXCL12 in primary cutaneous melanoma--biomarkers of potential utility? Hum Pathol. 2014 Oct; 45(10):2094-100.View Related Profiles. PMID: 25130395; DOI: 10.1016/j.humpath.2014.06.018;
  9. Matilde Sanchez-Kam, Paul Gallo, John Loewy, Sandeep Menon, Zoran Antonijevic, Jared Christensen, Christy Chuang-Stein and Thomas Laage. A Practical Guide to Data Monitoring Committees in Adaptive Trials. A Practical Guide to Data Monitoring Committees in Adaptive Trials. 2014; (48):316-326.
  10. Claudio Carini, Sandeep Menon and Mark Chang. Clinical and Statistical Considerations in Personalized Medicine. Taylor and Francis, CRC, Chapman & Hall. 2014.
Showing 10 of 28 results. Show More

This graph shows the total number of publications by year, by first, middle/unknown, or last author.

Bar chart showing 28 publications over 8 distinct years, with a maximum of 11 publications in 2014


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715 Albany St Talbot Building
Boston MA 02118
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