Adjunct Faculty in Operations Management, Quantitative Methods and Information Systems
Fellow of American Statistical Association
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.
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
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
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)
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