Emil M Friedman, PhD, Statistical Consultant

Hillside, NJ






BS from M.I.T,     PhD from Princeton,     MS from Case Western

Experienced statistician - strong background in chemistry, polymer science & engineering.

Consulting projects have covered wide variety of (often unique) situations.

Internal statistical consultant for R&D and manufacturing plants.  Led collaborative teams to:

           define questions and design experiments to answer them,

           improve processes & products,

           diagnose & solve wide range of technical & quality problems,

           remove unnecessary constraints and work around necessary ones.

Devised curriculum & successfully taught applied statistics in industry and online.

Extensive experience with JMP, SAS, and graphical display of data.

Extensive experience with wide variety of statistical methods.




Independent statistical consultant                                                                                         2003 - now

·        Calculated odds of winning various promotional games.  Devised new games.

·        Designed & analyzed experiments to test new method of removing secretions from endotracheal tubes.

·        Designed & analyzed trials to prevent infection by Israel Acute Paralysis Virus.

·        Interpreted statistical aspects of DNA data for counsel in criminal trial.

·        Identified unexpected spatial component in agricultural data. 

·        Designed and analyzed experiments related to smoke density & heat release (Schneller, Inc).

·        Statistically modeled market prices for Booz-Allen-Hamilton.

·        Cluster and related analyses for marketing firm.

·        Distributional analysis for jitter in oscilloscopes.

·        Modeled tire aging for Akron Rubber Development Lab (analogous to Rx stability below).

MannKind Corporation, Danbury, CT                                                                               2007 - 2015
Sr Principal Scientist, Principal Scientist, Statistician

·         Performed statistical analyses & consulted on study designs that supported regulatory submissions, ensured defensibility to external scrutiny, manufacturing, analytics, etc

·         Rapid Microbial Tests with Substantially Improved Statistical Properties (see publications)

·         Devised methods to extrapolate shelf life under multiple storage conditions (see publications)

·         Design & analysis of experiments.  Taught courses in same.

·         “Extremely complex problems of diverse scope…”

·         Representative to IPAC-RS Delivered Dose Uniformity (DDU) Working Group

Contract statistician at Bristol-Myers Squibb, New Brunswick, NJ                   2006-7, 2/1/16-8/25/17

·        Using Arrhenius equation and non-linear regression to try to predict long-term stability from combination of accelerated stability studies and early long-term data

·        Investigated alternatives to ICH Guidance Q1E when stability data available from ≥10 lots.

·        Calculate release and shelf life limits for quality department

·        Design of experiments & multiple criteria optimization for chemical processes.                   

·        Mathematically modeled continuous process wherein API was in the tablet coating.

·        Devised ad hoc sampling plan for unusual situation faced by other statisticians.

·        Modeled pharmaceutical stability, set tolerance intervals, recommended methodologies, etc.

·        Validated complex SAS program for Peto-Pike carcinogenicity studies. 


Keiser College – Online Adjunct Professor (Statistics)                                                       2004 - 2007

SAS Institute, Contract Instructor (Statistics Using JMP Software)                                     2003 - 2005


Goodyear Tire & Rubber, Research Div, Akron, OH, Technical ladder positions               1974 - 2003

“Goodyear Spirit Award”, 1989.


Quotes from performance appraisals:  “…recognized and much-sought internal consultant and expert in statistical methods and their application to real problem solving….Excellent listener and dissector of the key needs/wishes of his customers….Focuses their work to answer their desired questions, and creates experimental approaches specific to each problem.”  “Emil has internalized the principals of Total Quality Culture”.


·        Chaired curriculum committee.  Developed, wrote and taught many portions of internal statistics courses, including workshop in Multiple Criteria Optimization.  Associates consistently said that I made previously difficult concepts easy to understand.

·        Reduced measurement variation in production process by a factor of 10.

·        Identified root cause of expensive adhesion difficulties.

·        Prevented expensive (>$500,000/yr) & unnecessary change in bladder compound.

·        Invented and developed emulsion polymers & polymer processes to satisfy product needs.

·        Extensive use of a wide variety of statistical methods (eg, designed experiments, linear & non-linear regression, assessing measurement systems, sources of variation, Multiple Criteria Optimization, happenstance data, mixed models, ANOVA, ANOCOVA).

·        Identified root causes of major polymer deficiencies and devised improvements.

·        Synthesized polymers to meet specific needs.         

·        Software development as needed.


Polymer Science Dept, Univ of Mass (Roger S Porter), Post-doctoral research position,        1973 - 74

Regional Chair, MIT Educational Council                                                                                 ? - 2005

Cleveland VA Medical Center – Animal Care and Use Committee                                                2005
Math tutor - supposedly “lost” students achieved A’s in 11th grade math.                                      2004


4,254013  4,574,140  4,960,819  5,162,425




Invited speaker, ASM International (Akron Chapter), Akron Rubber Group Lecture Series (twice), national meeting of American Chemical Society.  Many internal seminars.



“Non-Transitivity, Correlation and Causation”, Emil M Friedman.  (2015) The American Statistician, 69:3, 257, http://www.tandfonline.com/eprint/wnpZDGAnFJh3cEuGZcen/full

 “In-Process Microbial Testing:  Statistical Properties of a Rapid Alternative to Compendial Enumeration Methods”, Emil M. Friedman, Mark Warner, Sam C. Shum, Fred Adair.  PDA Journal of Pharmaceutical Science and Technology, Vol 69, 264-269 (2015)  http://statisticalconsulting.org/PDAJournal2015Friedman264-9.pdf

"Challenges and Opportunities in Implementing the FDA Default Parametric Tolerance Interval Two-One Sided Test for Delivered Dose Uniformity of Orally Inhaled Products", Greg Larner, Andrew Cooper, Svetlana Lyapustina, Stefan Leiner, David Christopher, Helen Strickland, Michael Golden, Hans-Joachim Delzeit, Emil M. Friedman.  AAPS PharmaSciTech. Vol 12, 1144-56 (2011) http://www.ncbi.nlm.nih.gov/pubmed/21901649.

 “Stability Models for Sequential Storage”, Emil M Friedman and Sam C Shum.  AAPS PharmaSciTech , vol 12, pp 96-103 (2011).  DOI 10.1208/s12249-010-9558-x. (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3066345/)  Poster by Emil M Friedman at 33rd Annual Midwest Biopharmaceutical Statistics Workshop, Muncie, Indiana, May 24-26, 2010.

“Inspiratory Efforts Achieved in Use of the Technosphere® Insulin Inhalation System”, Chad C Smutney, Emil M Friedman, John M Polidoro and Nikhil Amin, Journal of Diabetes Science and Technology, vol 3, issue 5, Sept, 2009.  (http://www.ncbi.nlm.nih.gov/pubmed/20144434

“NIR Chemical Imaging to Guide/Support BMS-561389 Tablet Formulation Development”, L. Hilden, C.J. Pommiera, S. Badawya, Emil M. Friedman, International Journal of Pharmaceutics, 353(1-2), 283 (2008).  http://dx.doi.org/10.1016/j.ijpharm.2007.11.032

“Modality of Molecular Weight Distributions”, Emil M Friedman, Polymer Engineering and Science, 30, 569 (1990).  http://dx.doi.org/10.1002/pen.760301002  

“High Conversion Emulsion Polymerization in a Continuous Reactor:  Predictions Using Smith-Ewart Kinetics”, Emil M Friedman, J Polymer Sci, Polym Phys Ed, 18, 1771 (1980).  http://dx.doi.org/10.1002/pol.1980.180180809

“Elastomer Blends – Improved Strength…of Uncured Rubber Compounds”, Emil M Friedman, Richard G Bauer, and Diego C Rubio, in Polymer Alloys, ed D Klempner and K C Frisch (Plenum, NY, 1977), p 51.  Also presented at National ACS Meeting.

“Nematic-Like Flow Behavior in a Non-Steroidal Cholesteric Mesophase”, Emil M Friedman and Roger S Porter, Molecular Crystals and Liquid Crystals, 31, 47 (1975).  http://www.informaworld.com/smpp/content~db=all~content=a772880059

“Polymer Viscosity-Molecular Weight Distribution Correlations via Blending…”, Emil M Friedman and Roger S Porter, Transactions of the Society of Rheology, 49, 493, (1975).  http://dx.doi.org/10.1122/1.549382

“Effect of a Cholesteric Texture on X-ray Diffraction…Liquid Crystalline Polypeptides”, Emil M Friedman and Ryong-Joon Roe, Molecular Crystals and Liquid Crystals, 28, 437 (1974).

Solid State Morphology…Polypeptide Films”, Emil M Friedman, Courtney Anderson, Ryong-Joon Roe, and Arthur V Tobolsky, J Polymer Science, Polym Letters Ed, 10, 839 (1972).  http://onlinelibrary.wiley.com/doi/10.1002/pol.1972.130101104/abstract



Massachusetts Institute of Technology, Chemical Physics, BS.                                                       1968

Princeton University, Chemistry, MA, PhD, Chemistry. (Arthur V Tobolsky, supervisor)                1973

Case Western Reserve University, Applied Statistics, MS.                                                            1987