Statistical Outsourcing Services
Consultant Profiles
Home | Consultant Profiles | Services | Contact Us | Industry Links


At Statistical Outsourcing Service, we understand both the statistical aspects and the art of business. From development to post marketing, Statistical Outsourcing Services gives you the insight you need to achieve compliance and operating efficiency, so you can cut costs and boost revenue.

Resume of Steven Walfish 

Summary of qualifications


·          Experience applying advanced analytical solutions to business problems including linear and nonlinear modeling, sampling and experimental design.

·          Expertise in working on process improvement efforts including Six Sigma.

·          Project and client management.

·          Develop customized statistical training for different audience levels.

Professional experience


2005-Present             Statistical Outsourcing Services, President


·          LONZA

·          Lonza is a contract manufacturer for biological products.

·          Provided consultation on process validation for fermentation and purification processes.


·          DELMARVA

·          Reviewed and analyzed patient care survey data leading to program improvements and improved overall patient care.

·          Developed Return on Investment and Business Case documentation for Quality Improvement in a hospital setting.


·          ORIZON

·          Orizon is am Information Technology (IT) firm that develops data warehouse and business analytics applications for different branches of the US government.

·          Using SAS 9.0, developed an Extraction, Transformation and Loading (ETL) algorithm for a Business Intelligence (BI) application used in the mortgage industry.


·          STRYKER

·          Stryker Biotech is developing a biological product for healing bone after surgery.

·          Reviewed current “as-is” strategy for process validation.  Developed a new process for statistically analyzing process data to improve the report writing process.


·          AGENNIX

·          Agennix is a small biotech firm that is in Phase II development.

·          Developed statistical analysis of bioassay data for method validation


·          HGS

·          Human Genome Sciences (HGS) is a biotech firm that is in Phase III development.

·          Developed statistical analysis of bioassay data for method validation

·          PTi

·          PTi is a leading provider of training for the pharmaceutical and biotech industry.

·          Developed and presented on-site courses introductory statistics and regression analysis.


2001-2005     Human Genome Sciences, Senior Manager, Non-clinical Statistics


·          Nonlinear models for assay development.

·          Immunogenicity analysis.

·          Method validation.

·          Responsible for hiring and managing direct reports.


1998-2001     PricewaterhouseCoopers LLP, Senior Associate


·          Integrated a LIMS system into an Enterprise Resource Planning (ERP) system.

·          Customer Relationship Management (CRM) analysis for telecom company.

·          Market share analysis for pharmaceuticals using IMS database.

·          Litigation support.

1993-1998     Chiron Diagnostics, Statistical Methods Manager


·          Implementation of statistical methods in research, product development and manufacturing environments. 

·          Validation of next generation chemiluminescence instrument.

·          Assay qualification.

1991-1993     Ethicon Inc., a Johnson & Johnson Company, Quality Engineer/Biostatistician

·          Responsible for design and analysis of clinical studies for adhesion prevention.

·          Led marketing studies for comparing competitor products based on in-vivo studies.

·          Implemented statistical experimentation in process qualification and improvement.

1989-1991     Degussa Corporation, Quality Manager


1988-1989     IIT Research Institute, Statistician



Executive Masters of Business Administration (with Honors), May 1998

BOSTON UNIVERSITY, Boston, Massachusetts                                          


Masters of Science in Statistics, May 1992

RUTGERS UNIVERSITY, New Brunswick, New Jersey                                           


Bachelor of Arts in Statistics, May 1987


Software applications


SAS, JMP, Minitab, R and S-Plus




·          S. Walfish, “Statistically Rational Sampling Plans for Audits The Auditor December 2007

·          S. Walfish, “A Statistical Perspective on the ICH Q2A and Q2B Guidelines for Validation of Analytical Methods” BioPharm19(12) 28-37 (2006)

·          S. Walfish, “A Review of Statistical Outlier Methods” Pharmaceutical Technology 30(11) 82-88 (2006)

·          S. Walfish, “Statisticians Tackle More Than Clinical Trials” BioPharm 19(2) 44-45 (2006)

·          Optimization of animal-component-free medium for CHO cell growth and recombinant protein production using statistical design. R. Bhatia, C. Robberson, T. Osborne, S. Walfish, J. Zhang, 225th ACS National Meeting.

·          J. D. Williams, J. B. Birch and S. Walfish, “A Statistical Method to Account for Plate-to-Plate Variability in Multiple-Plate Bioassays,” BioPharm16(5) 66 (2003)




·          A Case Study in Process Characterization Experimental Budget, BioProcess International Conference Oct 2007

·          Data Analysis, Deciding What's Important and What's Not, MD&M Minneapolis

·          Statistically Rational Sampling Plans for Audits, 2007 ASQ Audit Division Conference

·          Monitoring and Measuring Quality System Performance through Quality, Regulatory and Compliance Metrics, MD&M New York

·          Process Capability Analysis and Setting Data Driven Specifications, Biopharm Webinar Series

·          Statistical Analysis Methods for Environmental Monitoring and Water Testing Programs, Biopharm Webinar Series

·          Applying Statistics Recommended by Regulatory Documents, 2006 Method Validation Conference, Institute for Validation Technology

·          Tackling Statistical Uncertainty in Method Validation, 2006 Method Validation Conference, Institute for Validation Technology

·          Lies, Damn Lies and Statistics; Understanding your Statistical Assumptions, 2006 Out of Specification Conference, Institute for Validation Technology

·          How Far is too Far?  Statistical Outlier Detection, 2006 Out of Specification Conference, Institute for Validation Technology

·          Using Statistical Methods in Stability Testing, 2004 CBI Research 6th Annual Stability Testing Forum

·          Using Statistical Tools for Process Validation, 2003 Barnett International Process Validation for Biopharmaceutical Manufacturing

·          Statistical Approaches to Process Validation, 2003 IBC Conference on Process Validation in Biologics

·          Optimizing Shipping Times Using Fractional Factorials, 2002 American Statistical Association, Quality and Productivity Research Conference.

·          Selling Pharmaceuticals in China, Capstone Project 1998 Executive MBA

·          Determining Reference Ranges, 1997 AACC Meeting

·          Statistics Primer: When is zero zero?, May 1996 NELRAD Annual Meeting


Professional Memberships


·          American Society of Quality

·          Certified Quality Engineer (CQE)

·          Biomedical Division Treasurer (2004-2005)

·          Biomedical Division Chair-elect (2005-2006)

·          Biomedical Division Chair (2006-2007)

·          Member of the Editorial Advisory Board for BioPharm magazine

PO Box 864, Olney, MD 20830-0864 301.325.3129 Fax: 240.559.0989