Biomedical Statistical Consulting

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

BIOSTATISTICS

For

Regulatory Studies of Medical Devices &

Pharmaceuticals

Greg Maislin

Principal Biostatistican

Consulting resume of Principal

Literature citation history of Principal

Letter to prospective clients

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)

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

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)

     Bayesian designs

     Sample size re-estimation (SSR) Designs

     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

NEXT ORTHOPEDIC PANEL MEETING

June 27-28, 2012: Orthopaedic and Rehabilitation Devices Panel

of the Medical Devices Advisory Committee Meeting

 Announcement

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)

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 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