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.
· 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.
Statistical Outsourcing Services, President
is a contract manufacturer for biological products.
Provided consultation on process validation for fermentation and purification processes.
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.
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 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.
is a small biotech firm that is in Phase II development.
Developed statistical analysis of bioassay data for method validation
Genome Sciences (HGS) is a biotech firm that is in Phase III development.
· Developed statistical analysis of bioassay data
for method validation
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.
Responsible for hiring and managing direct reports.
PricewaterhouseCoopers LLP, Senior Associate
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.
Diagnostics, Statistical Methods Manager
of statistical methods in research, product development and manufacturing environments.
· Validation of next generation
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
Masters of Business Administration (with Honors), May 1998
UNIVERSITY, Boston, Massachusetts
of Science in Statistics, May 1992
RUTGERS UNIVERSITY, New
Brunswick, New Jersey
of Arts in Statistics, May 1987
STATE UNIVERSITY OF NEW YORK
AT BUFFALO, Buffalo, New York
SAS, JMP, Minitab, R and S-Plus
· S. Walfish,
“Statistically Rational Sampling Plans for Audits” The Auditor December
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)
Walfish, “Statisticians Tackle More Than Clinical Trials” BioPharm 19(2) 44-45 (2006)
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
Statistics Recommended by Regulatory Documents, 2006 Method Validation Conference, Institute for Validation Technology
Statistical Uncertainty in Method Validation, 2006 Method Validation Conference, Institute for Validation Technology
Damn Lies and Statistics; Understanding your Statistical Assumptions, 2006 Out of Specification Conference, Institute for
How Far is too Far? Statistical Outlier Detection, 2006 Out of Specification Conference, Institute for Validation
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
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