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

(610) 645-5708
BSC@biomedstat.com

Maislin head shot

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