Ronald P. Kershner, Ph.D.
kershner@temple.edu
Ronald P. Kershner, Ph.D.
kershner@temple.edu
Experience
Assistant Professor
Department of Statistics
Fox School of Business
Temple University
Philadelphia, PA
Adjunct Instructor in Statistics
Department of Applied Economics and Statistics
University of Delaware
Newark, Delaware
Adjunct Instructor in Statistics
Department of Statistics
Fox School of Business
Temple University
Philadelphia, PA
Premier Research Group Limited, Philadelphia, PA, US
Vice President, Scientific Account Leadership-Biostatistics
 Responsible for coordination of proposal development and client
deliverables encompassing all aspects of data management and
biostatistics.
 Provide management oversight and leadership for the North
American Biostatistics and Data Operations Groups.
 Provide statistical consultation for clinical programs, including
protocol development, program strategy, and representation
with regulatory authorities, statistical review, report writing, and
complex statistical analysis.
Novella Clinical, Durham, NC, US
Global Head, Clinical Reporting
 Responsible for management and leadership for the Biostatistics
and SAS Programming Departments.
 Drive growth of revenue and profitability through the design and
implementation of cost effective, high quality research services
for each client
 Provide statistical consultation for clinical programs, including
protocol development, program strategy, and representation
with regulatory authorities, statistical review, report writing, and
complex statistical analysis.
 Serve as a liaison with sponsors and outside vendors as
appropriate to maintain rapport, facilitate negotiations, and help
solve problems collaboratively.
Ronald P. Kershner, Ph.D.
kershner@temple.edu
ZeeCRO (formally AAI Pharma), Wilmington, NC, US
Vice President, Biostatistics and Data Management
 Responsible for operational and financial oversight for Phase IIIV biostatistics and data management services at all North
America AAI locations.
 Serves in a senior leadership role and is responsible for
planning, development, implementation and delivery for all
aspects of statistics and data management services for clients.
 Significant interface with clients and cross-functional interaction
within AAI including operational support for business
development initiatives.
inVentiv Clinical Solutions, Indianapolis, IN, US
Senior Vice President, Clinical Operations
 Responsible for all operational and financial aspects of dedicated
teams and clinical outsourcing.
 Oversee and manage project management, clinical monitoring,
data management, biostatistics and medical writing.
 Responsible for project budgets, deliverables and profit center
management.
Omnicare Research, King of Prussia, PA, US
Global Senior Vice President, Data Management and Biostatistics
 Oversight and global leadership among four data centers within
the US and Europe.
 Responsible for insuring harmonization of all functional aspects
of data management and biostatistics on a world-wide level.
 Responsible for coordination of proposal development and client
deliverables encompassing all aspects of data management and
biostatistics.
Inveresk Research (formerly ClinTrials Research, Inc.), Research
Triangle Park, NC, US
Vice President, Medical Data Sciences
 Responsible for development of proposals, client interactions,
development of analysis plans for analysis of clinical trials, NDA
submissions, and key FDA interactions.
 Responsible for coordinating activities of the biostatistical, data
management, and SAS® programming functions.
Ronald P. Kershner, Ph.D.
kershner@temple.edu
Fujisawa USA, Inc., Deerfield, IL, US
Senior Director, Research Data Operations
 Responsible for all aspects of data entry, data management,
SAS programming, biostatistics and research systems
applications in support of pre-NDA clinical trials, and NDA
submissions.
 Established standard operating procedures and practices, which
would serve to increase the efficiency of the department and
ensure adherence to FDA regulations.
 Negotiate with consultants, contractors, and CROs to
supplement internal resources.
Centocor, Malvern, PA, US
Vice President, Biomedical Operations
 Responsible for rebuilding the Biomedical Operations
Department, defining the overall direction, and establishing
long-and short-term objectives.
 Supervise a staff of 52 with an operating budget of $6 million.
 Report to the Executive Vice President of Research and
Development.
Quintiles, Inc., Research Triangle Park, NC, US
Senior Director, Biostatistics
 Supervised staff of 24 and was responsible for biostatistics and
quality assurance.
 Provided supervision and guidance for staff and also defined the
overall scope, direction, and resource allocation for major
projects with outside clients.
 Extensive involvement in group, problem solving environments.
Reported to the Vice President of Operations.
Sterling Drug, Inc., Malvern, PA, US
Director, Biostatistics, 1984 to 1991
Assistant Director, Biostatistics, 1983 to 1984
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Directed all biostatistics and SAS programming applications in
support of clinical trials targeted for FDA submissions.
Reported to the Executive Vice President of Clinical Operations.
Direct experience in 22 NDA and SNDA submissions in
cardiovascular, bronchial asthma, and diagnostics.
Extensive experience with the FDA.
Headed multidisciplinary task force to develop worldwide
reporting strategies.
Ronald P. Kershner, Ph.D.
kershner@temple.edu
EDUCATION
1980 Ph.D. Cornell University, Ithaca, NY
Major: Biometry
1974 MA
The Pennsylvania State University, University Park, PA
Major: Statistics
1971 BS
The Pennsylvania State University, University Park, PA
Major: Biology
PROFESSIONAL AFFILIATIONS
Member,
Member,
Member,
Member,
Member,
Member,
Member,
Member,
Regional Advisory Board, Biometrics Society (1993 to 1995)
Steering Committee, Biostatistics Subsection of PMA (1987 to 1990)
Biometrics Society
Society for Clinical Trials
Drug Information Association
American Statistical Association
International Society of Clinical Biostatistics
Regional Advisory Board, Eastern Region Biometrics Society (1993 to 1996)
PUBLICATIONS, ABSTRACTS AND PRESENTATIONS
Kershner, R. “The Role of the Data Monitoring Committee”. Presented at the
Society for Clinical Research Associates, Baltimore, MD April 2014, Boston, MA
April 2012, Philadelphia, PA April 2010, Vancouver, BC Sept. 2008.
Kershner, R., “Monitoring Progress”, European Pharmaceutical Contractor
September 2009: 78-80.
Kershner, R. “Moving from Paper to EDC: A CRO Perspective” Presented at
the eTrials User Conference, Orlando, FL, October 2005, Eastern Technology
Council, Malvern, PA, January 2006, Clinical Trials Congress, Orlando, FL,
February, 2006 , EDC and Beyond, Las Vegas, NV, March, 2006.
Kershner, R., “Blinding DSMBs: Conservative Caution or Cause for Concern,”
Session Chair at the Thirty-sixth Annual DIA Meeting, San Diego, CA, June
2000.
Kershner, R., “Blinding DSMBs: Industry Views,” presented at the Thirty-sixth
Annual DIA Meeting, San Diego, CA, June 2000.
Ronald P. Kershner, Ph.D.
kershner@temple.edu
Kershner, R., "Utilization of DSMBs in Monitoring Clinical Trials: Issues for
Industry," presented at the Thirty -third Annual Drug Information Association
Meeting, Montreal, Quebec, Canada, June 24, 1997.
Kershner, R. and W. Fitzsimmons, “Relationship of FK506 Whole Blood
Concentrations and Efficacy and Toxicity after Liver and Kidney
Transplantation,” Transplantation 1996; 62: 920-926.
Kershner, R., “Surrogate Outcomes.” Presented at the Second Annual DIA
Biostatistics Meeting, Tokyo, Japan, August 30, 1995.
Kershner, R., “Correlation of FK506 Blood Concentrations to Rejection and
Toxicity in Cadaveric Kidney Transplant Patients.” Presented at the 14th
Annual Meeting of the American Society of Transplant Physicians, Chicago,
Illinois, May 17, 1995.
Kershner, R., "Statistical Pitfalls" (Invited Paper). Presented at the BioWest
Conference, San Diego, CA, June 8, 1994.
Kershner, R., G. Koch, S. Hackett and I. Amara, "Constructing and Evaluating
a Partially Complete Crossover Design for a Multi-dose Study,”
Communications in Statistics. Theory and Methods, Special Issue in Drug
Testing and Evaluation 1994; 23: 395-402.
Kershner, R., "A Note on the Three-Period Two-Treatment Crossover Designs,”
Controlled Clinical Trials 1992; 13: 238-249.
Kershner, R., "The PMA Position Paper: History and Background" (Invited
Paper). Presented at the PMA/FDA Workshop on Data Monitoring and Interim
Analysis, Washington, D.C., February 24, 1992.
Kershner, R., "Crossover Designs: Review and Perspective" (Invited Paper).
1991 DIA Statistics Workshop, Hilton Head, South Carolina, March 1991.
Kershner, R., "Development of an International Policy and Reporting Strategy
for Laboratory Abnormalities" (Invited Paper). DIA Euromeeting, Amsterdam,
Netherlands, October 1990.
Kershner, R., "Practical Aspects of Interim Analysis in the Pharmaceutical
Industry" (Invited Paper). Presented at the PMA Clinical Data Managers Group
Workshop, Chicago, Illinois, September 1990.
Kershner, R., "Interim Analysis in the Pharmaceutical Industry: Issues and
Recommendations" (Invited Paper). Presented at the Joint PSI/Biometrics
Society Meeting, London, England, May 1990.
Kershner, R., "Issues in Data Monitoring and Interim Analysis in the
Pharmaceutical Industry" (Invited Paper). Presented at the Annual Meeting of
the Northern New Jersey Chapter of the American Statistical Association, May
1989.
Ronald P. Kershner, Ph.D.
kershner@temple.edu
Kershner, R., "Data Monitoring and Drug Development" (Invited Paper).
Presented at the ENAR Regional Meeting, Boston, Massachusetts, March, 1988
and the Annual ISCB Meeting, Innsbruck, Austria, September 1989.
Kershner, R., "A Company Experience with Interim Analyses" (Invited Paper).
Presented at the Annual Meeting of the Biostatistics Subsection of the PMA,
San Diego, California, September 1987.
Kershner, R., and D. Zelterman, "Test for Qualitative Interactions.” Presented
at the Annual Meeting of the American Statistical Association, San Francisco,
California, August 1987.
Kershner, R., (with Biddle, T., et al.) "Comparison of Intravenous Milrinone and
Dobutamine for Congestive Heart Failure Secondary to Either Ischemic or
Dilated Cardiomyopathy,” American Journal of Cardiology, June 1987.
Kershner, R., "Repeated Measures Designs and Randomized Clinical Trails"
(Invited Paper). Presented at Statistical design: Theory and Practice. A
Conference in Honor of Walter T. Federer, Ithaca, New York, July 1987.
Kershner, R., "Optimal Two- and Three-Period Crossover Designs with and
without Baseline Measurements" (Invited Paper). Presented at the ENAR
Regional Meeting, Atlanta, Georgia, March 1986.
Kershner, R., "Registering Drugs with the FDA.” Presented at the
Administrative and Engineering Systems Colloquium, Institute of
Administration and Management, Union College, Schenectady, New York,
November 1983 and March 1986.
Kershner, R., J. Edelson, G. Park, J. Ryan, J. Angellotti, "Dose Proportionality
of Amrinone,” Clinical Pharmacology and Therapeutics 1983; 34: 190-194.
Kershner, R., "Revisiting Some Basic Concepts in Repeated Measures Designs.”
Presented at the Regional ENAR Meetings, Charleston, South Carolina.
Kershner, R., "On the Theory of Crossover Designs with Residual Effects.”
Unpublished Ph.D. Dissertation, Biometrics Unit, Cornell University, Ithaca,
New York.
Kershner, R., "Some Notes on the Evolution of the General Linear Model.”
Paper Number BU-678-M. Biometrics Unit, Cornell University, Ithaca, New
York.
Kershner, R., and W.T. Federer, "Two-Treatment Crossover Designs for
Estimating a Variety of Effects.” Paper Number BU-675-M. Biometrics Unit,
Cornell University, Ithaca, New York, Journal of the American Statistical
Association, 76, 612-619.
Kershner, R., "The Two-Treatment-Two-Period Crossover Design: A
Revisitation Using a Full Rank Cell Means Model.” Paper Number BU-699-M.
Biometrics Unit, Cornell University, Ithaca, New York.
Ronald P. Kershner, Ph.D.
kershner@temple.edu
Kershner, R., "Crossover Designs with Residual Effects: A Bibliography.” Paper
Number BU-667-M. Biometrics Unit, Cornell University, Ithaca, New York.
Searle, S. R. and R. Kershner, "Annotated Computer Output for Analysis of
Unbalanced Data: SPSS Anova.” Paper Number BU-660-M. Biometrics Unit,
Cornell University, Ithaca, NY.