Biostatistician

Education

****

Ph.D., Statistics

University of Chicago, Chicago, IL

1962

M.Sc., Statistics

University of Mysore, Karnataka, India

1960

B.Sc., Mathematics, Statistics, and Economics

University of Mysore, Karnataka, India

Skills

Statistical Analysis Plans and Statistical Analysis; SAS Programming, including PROC SQL, PROC GPLOT, PROC REPORT, PROC GLM, PROC CALIS, PROC PHREG, and PROC LOGISTIC; Report Writing

Professional Experience

Dr. Sanathanan received her PhD in Statistics from the University of Chicago and taught at the University of Illinois, Chicago, before starting a career in the pharmaceutical industry. She has had considerable experience with the design and analysis of clinical trials, while working for various pharmaceutical companies. She has also worked for the Food and Drug Administration (FDA) where she was Director of Research Methodology Planning, responsible for promoting innovative methods in research methodology toward fast-tracking drug approvals. Dr. Sanathanan is a Fellow of the American Statistical Association.

Dr. Sanathanan set up and managed the statistics department in Bangalore, India, for GlaxoSmithKline, where she recruited staff and trained them in SAS programming, preparing statistical analysis plans, statistical analysis, and report writing. She also set up and managed a CRO, Clinstitute, in Bangalore, for providing data management and statistical analysis services to pharmaceutical companies.

Dr. Sanathanan has developed a web app, Healthwiz, for monitoring and improving overall health. Healthwiz provides a diagnostic health score and the probability or risk of being diagnosed with metabolic syndrome, a harbinger of heart disease, stroke, type 2 diabetes, kidney disease, liver disease, and cancer. The health score and risk of metabolic syndrome are generated from data fed by the user, on gender, height, weight, systolic blood pressure, fasting glucose, triglycerides, and HDL-cholesterol, using a predictive model based on NIH data. The predictive model was developed using PROC LOGISTIC in SAS and was validated using PROC GLM and PROC CALIS in SAS.

2015 - present Independent Statistical Consultant (Developed Healthwiz; worked as a consultant for DP Clinical and was part of the team that helped Biogen get FDA approval for their drug.)

2014 - 2015 Statistical Consultant

GCE Solutions/Novartis Vaccines

Bloomington, Illinois, USA

2012 - 2014 Statistical Consultant

Reckitt Benckiser

Davenport, Florida, USA

2011 - 2012 Principal Research Statistician

PharmaNet/i3

Davenport, Florida, USA

2002 - 2011 President, Clinstitute Inc.

Bangalore, India

Consultant, GlaxoSmithKline

1996 - 2002

Consultant

GlaxoWellcome; Intercardia

Research Triangle Park, NC

GlaxoWellcome; GlaxoSmithKline

Bangalore, India

1995 - 1996

Vice President, Data Management & Biostatistics

ClinTrials Research, Inc.

Research Triangle Park, NC

1991- 1995

Vice President, Biostatistics, Clinical Data Systems & Technical Writing

Institute for Biological Research & Development, Inc.

Blue Bell, PA

1989 - 1991

Director, Research & Methodology Planning Staff

Group Leader, Division of Biometrics

Food & Drug Administration (Center for Drug Evaluation & Research) Rockville, MD

1986 - 1989

Director, Research Statistics

SmithKline Beecham

Upper Merion, PA

1985 - 1986

Associate Director, Research Statistics

Ciba-Geigy Corporation

Summit, NJ

1982 - 1985

Senior Statistician

Abbott Laboratories

Abbott Park, IL

1978 - 1982

Group Leader, Statistics & Computer Science

Visiting Scientist

Argonne National Laboratory, Division of Environmental Impact Studies Argonne, IL

1968 - 1978

Associate Professor (Tenured) of Quantitative Methods

Director of Graduate Studies

Assistant Professor of Quantitative Methods

University of Illinois

Chicago, IL

Awards and Honors

Publications

Fellow, American Statistical Association

Member, Editorial Board of Clinical Trials and Meta-Analysis

Associate Editor, Special JASA Biopharmaceutical Issue

Member, PMA BBS Steering Committee

Member of the Volwiler Society, Abbott Laboratories

University Fellow, University of Chicago

First Rank in the University for the M.Sc. Degree, University of Mysore

Baba Gold Medal for First Rank in English, University of Mysore

On an Allocation Problem with Multistage Constraints”, Operations Research, 19 (1971), 1647-1633.

“Estimating the Size of a Multinomial Population”, Annals of Mathematical Statistics, 43 (1972), 142-152.

“Models and Estimation Methods in Visual Scanning Experiments”, Technometrics, 14 (1972), 813-830.

“A Comparison of Some Models in Visual Scanning Experiments”, Technometrics, 15 (1973), 67-78.

“Model Building in Multiple Linear Regression”, Proceedings of the Business and Economic Statistics Section, American Statistical Association (1973), 563-564.

“Critical Power Function and Decision Making”, Journal of the American Statistical Association, 69 (1974), 398-402.

“Some Properties of the Logistic Model for Dichotomous Response”, Journal of the American Statistical Association, 69 (1974), 744-749.

“Discriminant Analysis”, in Introductory Multivariate Analysis, (D.K. Amick and J.H. Walberg, eds), McCutchan Publishing Corporation (1975), 236-256.

“Preliminary Testing and the Minimax Regret Criterion in Regression Analysis”, Proceedings of the Business and Economic Statistics Section, American Statistical Association (1976), 575-578.

“Estimating the Size of a Truncated Sample”, Journal of the American Statistical Association, 72 (1977), 669-672.

“Normed Measures of Interactions in Multidimensional Contingency Tables” (L. Sanathanan and W. Bridges), Proceedings of the Social Statistical Section, American Statistical Association, (1978).

“Convergence Rate in the Empirical Bayes Solution to the Two-Action Problem” (with J. Van Ryzin and S.A. Tyler), Argonne National Laboratory BIMED Annual Report (1965), ANL-7136, 89-90.

“On A Minimization Problem” (with S.A. Tyler), Argonne National Laboratory BIMED Annual Report (1965), ANL 7136, 82-83.

“On the Estimation of the Size Distribution from Plane Sections” (with S.A. Tyler), Argonne National Laboratory BIMED Annual Report (1965), ANL-7136, 81-82.

“Dynamic Modeling of Neighborhood Transition” (L. Sanathanan, W. O’Neill, and J. McDonald), Proceedings of the Social Science Section, American Statistical Association (1977), 471-475.

“The Logistic Model and Estimation of Latent Structure” (L. Sanathanan and S. Blumenthal), Journal of the American Statistical Association, 73 (1978), 794-799.

“A Balancing Criterion for Decisions Based on Testing”, Information Systems and Policy Analysis, 3 (1979).

“Estimation from Truncated Data with Inverse Binomial Sampling” (S. Blumenthal and L. Sanathanan), Commun. Statis. Theor. Meth., A9 (10), 997-1017 (1980).

“Latent Structure Estimation for Assessing Gain in Ability”, Proceedings of the CAT Conference (1979).

“Random Numbers Spring from Alpha Decay” (with N. Frigerio, M. Morley, N. Clark and S. Tyler), ANL/ES-111, Argonne National Laboratory (1981).

“Health Effects of Synfuel Technologies – A Review” (L. Sanathanan, C. A. Reilly, S.A. Marshall and K. Wilzbach), ANL/ES-111, Argonne National Laboratory (1981)

“The Inferred Referendum – A Rule for Committee Decisions”, (with A. Wolsky), Theory and Decision, 13 (1981).

“Health Effects of Coal Combustion”, (with P. Walsh, et. Al.), ORNL/Oak Ridge National Laboratory (1982).

“Calculation of Hydraulic Conductivity” (with A.B. Gureghian and B.R. Stitt), ANL/EIS-14, Argonne National Laboratory (1982).

“Statistical Decision Procedures for Uranium Mill Tailings Remedial Action” (L. Sanathanan, R. McDonald and C. Roberts), Proceedings of the International Symposium on Management of Wastes from Uranium Mining and Milling (1982).

A Chapter on “Statistical Considerations of Monitoring”, in the Generic Handbook on Environmental Monitoring for Low-Level Radioactive Waste Disposal Sites, ANL 038 02 82, U.S. DOE (1982).

Summary of the “Workshop of Probabilistic Models in Risk Analysis”, and contributor to discussion paper on “Risk Analysis”, Proceedings of the 1981 DOE Statistical Symposium (June 1982).

“Empirical Bayes Approach to Risk Estimation”, Proceedings of the 1981 DOE Statistical Symposium (June 1982).

“Handling Missing Values in Repeated Measures Analysis” (with R. Gagnon and J. Lue), Proceedings of the 1988 annual ASA Conference.

“Systematic Drug Receptor Mapping: A New Approach to the Analysis of Conformational Energy Calculations of Flexible Molecules with Applications to Dopaminergic Agonists” (L. Sanathanan, E. Danaher, K. Kim and Y. Martin), Journal of Computational Chemistry, 8 (1987), 1075-1083.

“Trimmed Logit Method for Estimating the ED50 in Quantal Bioassay” (L. Sanathanan, E. Gade and N. Shipkowitz), Biometrics, 43 (1987), 825-832.

“A Blind Reanalysis of a Random Subset of NCI Bioassay Studies: Agreement Between Rats and Mice” (L. Sanathanan, T. Lin and R. Carr), Fundamental and Applied Toxicology, 12 (1989) 191-201.

“A Two-Stage Procedure to Allow for Sample Size Adjustment” (D. Hoberman, L. Sanathanan, S. Dubey), Proceedings of the 1990 Annual ASA Meeting.

"Random Effects Modeling in Population Kinetic/Dynamic Analysis", DIA

(Drug Information Association) Journal, 25 (3) (1991), 703-718.

"Randomization, PK-Controlled Dosing, and Titration: An Integrated

Approach for Designing Clinical Trials" (L. Sanathanan, C. Peck, R.

Temple, R. Lieberman, G. Pledger), DIA Journal, 25 (3) (1991), 425-431.

"The Randomized Concentration-Controlled Trial: An Evaluation of Its

Sample Size Efficiency" (L. Sanathanan, C. Peck), Controlled Clinical

Trials, 12 (1991), 780-794.

"Pharmacodynamic Measures Based on CD4 Lymphocyte Counts for Assessing the Effect of Anti-HIV Therapy" (L. Sanathanan, C. Peck) New Strategies in Drug Development and Clinical Evaluation: The Population Approach, pp 207-221, Edited by M. Rowland and L. Aarons, Brussels, Belgium, 1992.

"Opportunities for Integration of Pharmacokinetics, Pharmacodynamics, and Toxicokinetics in Rational Drug Development" (co-authored with C. Peck, et al), Pharmaceutical Research, 9 (6) (1992), 826-833.

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