Last Name

Sandeep Menon, PhD

TitleAdjunct Assistant Professor
InstitutionBoston University School of Public Health
Address715 Albany St Talbot Building
Boston MA 02118
ORCID ORCID Icon0000-0002-7285-4537
 Research Expertise & Professional Interests
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. 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.
    View in: PubMed
  2. 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. 2016 Jan 01; 962280216684528. PMID: 28067121.
    View in: PubMed
  3. Wang J, Chang M, Menon S. Biomarker informed add-arm design for unimodal response. J Biopharm Stat. 2016; 26(4):694-711. PMID: 26010506.
    View in: PubMed
  4. 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.
    View in: PubMed
  5. Wu J, Menon S, Chang M. An Adaptive Staggered Dose Design for a Normal Endpoint. J Biopharm Stat. 2015; 25(4):731-56. PMID: 24904986.
    View in: PubMed
  6. 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.
  7. 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. PMID: 25130395.
    View in: PubMed
  8. 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.
  9. Claudio Carini, Sandeep Menon and Mark Chang. Clinical and Statistical Considerations in Personalized Medicine. Taylor and Francis, CRC, Chapman & Hall. 2014.
  10. Jing Wang, Mark Chang, and Sandeep Menon. Chapman and Hall/CRC. Biomarker-Informed Adaptive Design. 2014.
  11. Joseph Wu, Sandeep Menon, and Mark Chang. Chapman and Hall/CRC. Fitting the Dose: Adaptive Staggered Dose Design. 2014.
  12. Lingyun Liu, Fred Immermann, and Sandeep Menon. Chapman and Hall/CRC. Multiplicity in Pharmacogenomics. 2014.
  13. Xu S, Hua SY, Menton R, Barker K, Menon S, D'Agostino RB. Inference of bioequivalence for log-normal distributed data with unspecified variances. Stat Med. 2014 Jul 30; 33(17):2924-38. PMID: 24403216.
    View in: PubMed
  14. Xu S, Barker K, Menon S, D'Agostino RB. Covariate effect on constancy assumption in noninferiority clinical trials. J Biopharm Stat. 2014; 24(6):1173-89. PMID: 25036666.
    View in: PubMed
  15. Xu S, Hua SY, Menton R, Barker K, Menon S, D'Agostino RB. Inference of equivalence for the ratio of two normal means with unspecified variances. J Biopharm Stat. 2014; 24(6):1264-79. PMID: 25033269.
    View in: PubMed
  16. Ananthakrishnan R, Menon S. Design of oncology clinical trials: a review. Crit Rev Oncol Hematol. 2013 Oct; 88(1):144-53. PMID: 23623356.
    View in: PubMed
  17. Pradhan V, Menon S, Das U. Corrected profile likelihood confidence interval for binomial paired incomplete data. Pharm Stat. 2013 Jan-Feb; 12(1):48-58. PMID: 23296487.
    View in: PubMed
  18. Menon S, Massaro JM , Pencina M, Lewis J and Wang YC . Performance Evaluation of commonly used sample size re-estimation methods. Communication in Statistics – Simulation and Computation. 2013; (00):1-13.
  19. Katz T and Menon S. The next generation of trial design innovation: strategies, methods and logistical considerations for flexible trial design. Clinical Investigation. 2013; 2(3):109-112.
  20. Antonijevic Z, Gallo P, Chuang-Stein C, Dragalin V, Loewy J, Menon S, Miller E,Morgan C and Sanchez M . Views on Emerging Issues Pertaining to Data Monitoring Committees for Adaptive Trials. Therapeutic Innovation & Regulatory Science. 2013.
  21. Ananthakrishnan R and Menon S . Integration of cell biology, pharmacological modeling and statistical analysis: part I: cell biology and PK/PD in the Oncology paradigm. Critical Reviews in Onco Hematology. 2012; 2(83):153-62.
  22. Ananthakrishnan R and Menon S. Integration of cell biology, pharmacological modeling and statistical analysis: part II: Design and statistical analysis of oncology clinical trials, and detection and treatment of cancer. Critical Reviews Onco Hematology. 2012; 2(83):163-69.
  23. Menon S, Chang M. Optimization of adaptive designs: efficiency evaluation. J Biopharm Stat. 2012; 22(4):641-61. PMID: 22651106.
    View in: PubMed
  24. Menon, S, Massaro, J., Lewis, J., Pencina, M., Wang, YC., and Lavin, P. Sample Size Calculation for Poisson Endpoint Using the Exact Distribution of Difference Between Two Poisson Random Variables. Statistics in Biopharmaceutical Research. 2011; 3(3):497-504.
  25. Phillips TJ, Symons J, Menon S. Does hormone therapy improve age-related skin changes in postmenopausal women? A randomized, double-blind, double-dummy, placebo-controlled multicenter study assessing the effects of norethindrone acetate and ethinyl estradiol in the improvement of mild to moderate age-related skin changes in postmenopausal women. J Am Acad Dermatol. 2008 Sep; 59(3):397-404.e3. PMID: 18625536.
    View in: PubMed
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