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Faculty Directory A to Z



Sandeep   Menon
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Sandeep Menon

Adjunct Faculty in Operations Management, Quantitative Methods and Information Systems


  • Ph.D. Biostatistics, 2010 - Boston University
  • Master’s in Public Health, 2003 - Boston University
  • Medical Internship, 1998 - Mumbai
  • Bachelor Homoeopathic Medicine and Surgery, 1997 - Karnataka (Bangalore) University, India

  • Cohen S, Clowse M, Pardo P, Bhattacharya I, Menon S, Gourley I and Diehl A(2016): Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of SBI-087, a CD20-Directed B-cell Depleting Agent: Phase I Dose Escalating Studies in Patients with Either Mild Rheumatoid Arthritis or Systemic Lupus: Clinical Therapeutics, Volume 38:6,1417-1434
  • Damjanov N, Tlustochowicz M, Aelion J, Greenwald M, Diehl A, Bhattacharya I, Peeva E, Menon M, and Gourley I (2016): 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: The Journal of Rheumatology; 43:12; doi:10.3899/jrheum.160146
  • Laage T, Loewy J, Menon S, Miller E, Pulkstenis E, Kan-Dobrosky N and Coffey C (2016): Ethical considerations in novel adaptive design clinical trials: Therapeutic Innovation & Regulatory Science, 1-10
  • Wu J, Banerjee A, Jin B, Menon S, Martin S and Heatherington A (2016): Clinical dose response for a broad set of biological products: A model-based meta-analysis: Statistical Methods in Medical Research, 0(0): 1-28
  • Yu C-R, Riggs M, Menon S and Weerahandi S (In Print): Exact Inference for 3-treatment, 3-period, 6-Sequence Crossover Design (Accepted at Pharmaceutical Statistics)
  • Mathew T, Menon S, Perevozskaya I and Weerahandi S (2016): Improved Prediction Intervals in heteroscedastic Mixed-Effects Models: Statistics and Probability Letters, 114, 48-53
  • Pritchett Y, Menon S, Marchenko O, Antonijevic Z, Miller E, Sanchez-Kam M, Morgan-Bouniol C, Nguyen H and Prucka W (2015): Sample Size Re-estimation Designs in Confirmatory Clinical Trials - Current State, Statistical Considerations and Practical Guidance: Statistics in Biopharmaceutical Research,7:4, 309-321, DOI: 10.1080/19466315.2015.1098564
  • Wang, J., Chang, M. and Menon, S (2015). “Biomarker Informed Add-arm for Unimodal Design”, Journal of Biopharmaceutical Statistics:1-18, doi:10.1080/10543406.2015.1052474
  • Wu J, Menon S and Chang M (2015): An Adaptive Staggered Dose Design for a Normal Endpoint. Journal of Biopharmaceutical Statistics; 25(4):731-56.
  • Zou, B., Jin, B., Koch, G. G., Zhou, H., Borst, S. E., Menon, S. and Shuster, J. J. (2015), On model selections for repeated measurement data in clinical studies. Statistics in Medicine, 34: 1621–1633. doi: 10.1002/sim.6414.
  • Hammerman K, Elena P, Ahmad A, Menon S, Afsharvand M, Qu RP, Cheng J, Syed J, Zhan Y, O'Neill S, Williams P, Cox S, Ann L. and Beidler D (2015): Monoclonal antibody against macrophage colony-stimulating factor suppresses circulating monocytes and tissue macrophage function but does not alter cell infiltration/activation in cutaneous lesions or clinical outcomes in patients with cutaneous lupus erythematosus: Clinical & Experimental Immunology 183(2).doi: 10.1111/cei.12705
  • Xu S, Hua SY, Menton R, Barker K, Menon S, D''Agostino RB (2014). Inference of bioequivalence for log-normal distributed data with unspecified variances. Statistics in Medicine. 2014 Jul 30; 33(17):2924-38 (PMID: 24403216 )
  • Wang J, Menon S, Chang M (2014) Finding Critical Values to Control Type I Error for a Biomarker Informed Two-Stage Winner Design. Journal of Biometrics & Biostatistics 5:207. doi: 10.4172/2155-6180.1000207
  • Cheng YS , Ray S , Chang M and Menon S (2014): Statistical Monitoring of Clinical Trials With Multiple Co-Primary Endpoints Using Multivariate B-value : Statistics in Biopharmaceutical Research - Vol. 6, Iss. 3.
  • Xu S, Barker K, Menon S and D’Agostino RB (2014) : Covariate Effect on Constancy Assumption in Noninferiority Clinical Trials, Journal of Biopharmaceutical Statistics, 24:6, 1173-1189, DOI: 10.1080/10543406.2014.941993
  • Mitchell B, Leone D, Feller K, Menon S, Bondzie P, Yang S, Park HY, Mahalingam M (2014): Protein expression of the chemokine receptor CXCR4 and its ligand CXCL12 in primary cutaneous melanoma—biomarkers of potential utility? Human Pathology (2014) 45, 2094–2100
  • Sanchez-KM, Gallo P, Loewy J, Menon S, Antonijevic Z, Christensen J, Chuang-Stein C, and Laage T. A Practical Guide to Data Monitoring Committees in Adaptive Trials. Therapeutic Innovation & Regulatory Science. May 2014 48: 316-326.
  • Xu S, Hua SY, Menton R, Barker K, Menon S and D'Agostino RB. (2014) : Inference of equivalence for the ratio of two normal means with unspecified variances. Journal of Biopharmaceutical Statistics. 24(6):1264-79. doi: 10.1080/10543406.2014.941990.
  • Wang,J.,Chang,M.,Menon,S,Wang,L.(2014).“BiomarkerInformedPick-the-WinnerDesign”.(SubmittedtoJournalofBiopharmaceuticalStatistics)
  • AnanthakrishnanRandMenonS(2013): DesignofOncologyClinicalTrials:AReview:CritRevOncolHematol,88(1):144-53.doi:10.1016/j.critrevonc.2013.03.007.Epub2013Apr25.
  • AntonijevicZ,GalloP,Chuang-SteinC,DragalinV,LoewyJ,MenonS,MillerE,MorganCandSanchezM(2013): ViewsonEmergingIssuesPertainingtoDataMonitoringCommitteesforAdaptiveTrials.: TherapeuticInnovation&RegulatoryScience00(0)1-8(doi:10.1177/2168479013486996)
  • KatzTand MenonS(2013):Thenextgenerationoftrialdesigninnovation:strategies,methodsandlogisticalconsiderationsforflexibletrialdesign.ClinicalInvestigation3(2):109-112
  • MenonS,MassaroJM,PencinaM,LewisJandWangYC(2013):  PerformanceEvaluationofcommonlyusedsamplesizere-estimationmethods: CommunicationinStatistics–SimulationandComputation:00:1–13
  • Pradhan,V.,Menon,S.andDas,U.(2013),Correctedprofilelikelihoodconfidenceintervalforbinomialpairedincompletedata.PharmaceuticalStatistics,1248–58(doi: 10.1002/pst.1551)
  • AnanthakrishnanR,MenonS(2012): Integrationofcellbiology,pharmacologicalmodelingandstatisticalanalysis:partI:cellbiologyandPK/PDintheOncologyparadigm.CritRevOncolHematol.Aug;83(2):153-62.
  • MenonSandChangM(2012): Optimizationofadaptivedesigns:EfficiencyEvaluation:JournalofBiopharmaceuticalStatistics,22:641–661
  • AnanthakrishnanR,MenonS(2012): Integrationofcellbiology,pharmacologicalmodelingandstatisticalanalysis:partII:Designandstatisticalanalysisofoncologyclinicaltrials,anddetectionandtreatmentofcancer.CritRevOncolHematol.Aug;83(2):163-69.
  • Menon, S, Massaro,J.,Lewis,J.,Pencina,M.,Wang,YC.,andLavin,P.(2011)"SampleSizeCalculationforPoissonEndpointUsingtheExactDistributionofDifferenceBetweenTwoPoissonRandomVariables,StatisticsinBiopharmaceuticalResearch,Vol.3,No.3,497-504. 
  • AggreyG,SullivanM,CrosbySandMenonS(2011): ReproductiveHealthofHIVInfectedRefugeeWomeninBoston,Massachusetts(AbstractpublicationandpresentedatInfectiousDiseaseSocietyofAmerica–IDSA)
  • PhilipsT,SymonsJandMenonS(2007):DoesHormoneReplacementTherapy(LowDose)improvesagerelatedskinchangesinpostmenopausalwomen,Ref.: Ms.No.JAAD-D-07-00677R3JournaloftheAmericanAcademyofDermatology
Book Publications
  • Clinical and Statistical Considerations in Personalized Medicine
    (Published April’ 2014 – CRC, Chapman & Hall)
    Edited by Claudio Carini, Sandeep Menon and Mark Chang
  • Modern Approaches to Clinical Trials Using SAS - Classical, Adaptive and Bayesian Methods
    (Published October’ 2015 – SAS Publications)
    Edited by Sandeep Menon and Richard Zink
  • Biosimilar Clinical Development - Scientific Considerations and New Methodologies
    (Published January’ 2017 – CRC Publications)
    Edited by Kerry Barker, Sandeep Menon, Ralph D’Agostino Sr, Siyan Xu and Bo Jin
Book Chapters
  • Jin B, Menon S, Barker K and D’Agostino R (in print). Biosimilars for drug development: the time is now! (Chapter 1: Biosimilar Clinical Development – CRC press)
  • Jin B, Menon S, Barker K and Hua S (in print). Interchangeability between Biosimilar and Innovator Drug Products (Chapter 4: Biosimilar Clinical Development – CRC press)
  • Xu S, Barker K, Menon S, and D’Agostino R (in print). Accounting for covariate effect to show non-inferiority in Biosimilars. (Chapter 6: Biosimilar Clinical Development – CRC press)
  • Xu S, Hua S, Menton R, Barker K, Menon S, and D’Agostino R (in print). Novel Method in Inference of Equivalence in Biosimilars. (Chapter 7: Biosimilar Clinical Development – CRC press)
  • Wu J, Menon S, Zink, R and Perevozskaya I. (2015). “Designing and Monitoring Group Sequential Clinical Trials”. (Chapter 2 : Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods - SAS publications)
  • Perevozskaya, I and Menon, S (2015). “Sample Size Re-estimation”. (Chapter 3 : Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods - SAS publications)
  • Huang, B, Wang, J and Menon, S (2015). “Adaptive Population Enrichment”. (Chapter 9 : Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods - SAS publications)
  • Wang, J., Chang, M., Menon, S, Wang, L. (2014). “Biomarker Informed Adaptive  Design”. (Chapter 5 : Clinical and Statistical Considerations in Personalized Medicine , CRC press)
  • Wu J, Menon S and Chang M (2014): Fitting the dose - adaptive staggered dose design”. (Chapter 6 : Clinical and Statistical Considerations in Personalized Medicine , CRC press)
  • Liu L, Immermann F and Menon S (2014): Multiplicity in Pharmacogenomics  (Chapter 8 : Clinical and Statistical Considerations in Personalized Medicine , CRC press)
  • 2015-2016: Outstanding Contribution to Biopharmaceutical Applied Statistical Symposium
  • 2015-2016  Upjohn Award
  • 2010-2014  Individual Performance Award - Bio-therapeutics Research, Pfizer Inc
  • 2012 Recognition for Exceptional teaching (Boston University – Department of Biostatistics)
  • 2010 Awarded Student Financial Grant - Midwest Biopharmaceutical Statistics Workshop
  • 2009 Mu Sigma Rho Inductee for Academic Excellence
  • 2008 Silver Team Award in appreciation for achieving aggressive timelines
  • 2003 Recipient of GRASP fellowship
  • 1996 University and State 3rd Ranker (Third Year Medicine Board Exam).  
  • 1994 University and State 2nd Ranker (First Year Medicine Board Exam).
  • 1997 Dr.B.D; Jatti Medical College Board Exams Topper - 1st Ranker
  • 1996 Dr.B.D; Jatti Medical College Board Exams Topper - 1st Ranker
  • 1995 Dr.B.D; Jatti Medical College Board Exams Topper - 1st Ranker
  • 1994 Dr.B.D; Jatti Medical College Board Exams Topper - 1st Ranker
Consulting Experience
  • GENZYME CORPORATION - Performed ad-hoc analysis on Phase IV trials. Inidication – Non-Hodgkin’s Lymphoma.
  • OGENIX INC - Provide statistical consultation on randomization and protocol design. Indication – Indication–Diabetic Foot.
  • ICET INC - Provide statistical consultation on the protocol design and interacting with the FDA on the optimal design and analysis. Indication - urinary tract infection (UTI)
Teaching Experience
  • Spring’2013 and 2015 : SPH BS 856 Adaptive Designs in Clinical Trials (Advanced Course)
  • Spring’2010-Fall’2012 : SPH BS 723 Introduction to Statistical Computing
  • Spring’2010-SPH BS 851 and BS 861 Applied Statistics in Clinical Trials II Fall’2010
  • Fall’2009 SPH BS 861 Applied Statistics in Clinical Trials II
  • Spring’2009 SPH BS 851 Applied Statistics in Clinical Trials I
  • Fall ’2008 SPH BS 821 Analysis of Categorical Data
  • Fall ’2002 SPH BS 701 Introduction of Biostatistics