Biomedical Statistical Consulting
Since 1986 Providing Quality in Design, Implementation, and Presentation

(610) 645-5708
BSC@biomedstat.com

	BIOSTATISTICS For Regulatory Studies of Medical Devices & Pharmaceuticals
Greg Maislin Principal Biostatistican Literature citation history of Principal NIH funded research history of Principal Consulting resume of Principal Letter to Sponsors Power points of Presentations · Frequentist Operating Characteristics of Bayesian Posterior Designs, Joint Statistical Meetings, Miami, FL, August 2011. · Propensity Scores in Medical Device Trials, Joint Statistical Meetings, Vancouver CA, August 2010. · The Effects of Obstructive Sleep Apnea and Visceral Fat on Insulin Resistance: The Iceland Sleep Cohort (ISAC), San Antonio TX, APSS 2010. · Parsimonious Statistical Modeling of Inter-Individual Response Differences to Sleep Deprivation, Sponsored by USAMRMC and the Institutes for Behavior Resources, Inc., Baltimore MD, 2008 · Predicting Obstructive Sleep Apnea, Chest 2008, Philadelphia Web Pages That Perform Statistical Calculations (Maintained by John C. Pezzullo) Free Statistics Calculators (Maintained by Daniel S. Soper) Karl Wuensch's Statistical Help Page (a nice collection of misc. but useful help topics) StatLib: Data, Software and News from the Statistics Community	Design of medical device trials Design of post approval studies (PAS) Design of post market surveillance studies (522) Group sequential (GS) designs with interim analyses for superiority and/or futility Adaptive designs with sample size re-estimation (AD-SSR) Bayesian design with non-informative and informative priors Propensity score (PS) designs for non-randomized trials Imputation methods for missing clinical endpoints Regulatory representation at pre IDE and other scheduled meetings Panel meeting presentation On-line materials for 2012 ORTHOPEDIC PANEL MEETINGS September 21, 2012 June 27-28, 2012 Statistics Interest Group for Medical Devices and Diagnostics (SIGMEDD)– an Interest Group of the American Statistical Association McNemar's Test for Correlated Proportions in the Marginals of a 2x2 Contingency Table (includes Exact Test and Exact confidence interval for odds ratio) By Vassar Stats (Richard Lowry) Richard Lowry's VassarStats: User friendly site that performs a number of fundamental statistical computations. MARTINDALE'S CALCULATORS ON-LINE CENTER STATISTICS: A-Z Globally Accessible Statistical Procedures
The Astronomy Picture of the Day
Google Scholar the Principal Biostatistician
Criterium, Inc., our international data management/clinical monitoring colleagues
Links to Our Association Affiliations
Click here for the American Statistical Association
Click here for the Institute of Mathematical Statistics
Click here for the Drug Information Association
Click here for the International Biometric Society
Click here for the Society for Clinical Trials
Links to Good Statistical Methods Pages
David A. Kenny’s Causal Analysis Page (mediation effects)
David A. Kenny’s Structural Equation Modeling Page
Interpreting Diagnostic Tests (Thomas G. Tape, MD)
Rich Ulrich's stat-FAQ not-quite-a-Kwik-index
Statistical Methods for Rater Agreement (John Uebersax) The Little Handbook of Statistical Practice (by Gerard E. Dallal, Ph.D)
22 statistical distributions (interactive using Excel)
RiceVirtual Lab in Statistics including elementary on-line textbook (HyperStat Online)
Collection of Biostatistics Research Archive
Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 5.1.10 [updated March 2011].
Links to Key Regulatory Guidance
ICH E3: Guideline for Industry – Structure and Content of Clinical Study Reports
ICH E9: Guideline for Industry – Statistical Principals for Clinical Trials
ICH E10: Guideline for Industry – Choice of Control Group
Guidance for Industry and FDA Staff Clinical Data Presentations for Orthopedic Device Applications Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials DRAFT GUIDANCE: This guidance document is being distributed for comment purposes Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
SAS SAS OnlineDoc© 9.1 SAS MACRO SOURCES SAS Coding Tips and Techniques from SAS Consultant Special Interest Group
SAS Publication Samples Library Mayo Clinic Locally Written SAS Macros SAS Macros that Convert a Directory of Transport Files SPSS and SAS procedures for estimating indirect effects in simple mediation models.  Appendices A and B from Preacher, K. J., & Hayes, A. F. (2004). Behavior Research Methods, Instruments, and Computers, 36, 717-731 SAS Macros for Microarray analysis