SERVICES

Biostatistics

Westat offers comprehensive biostatistical support for interventional and observational studies with a focus on Phase I to IV randomized controlled clinical trials and multisite investigations.

Westat’s expertise extends to comprehensive biostatistical support for interventional and observational studies, including Phase I to IV randomized controlled trials and multisite investigations.

Comprehensive Support

Our team’s years of combined expertise make for flexible, rigorous solutions to address end-to-end biostatistical needs. We provide data analysis methods for both interim and final analyses following established industry standards – pivoting to meet the needs of your study and reporting requirements at each stage of the process. Westat’s biostatistical services include:

  • Designing conventional and adaptive studies
  • Developing statistical sections of protocols
  • Calculating sample size/power
  • Conducting simulations to assess probability of trial success
  • Developing randomization procedures
  • Accounting for missing values and multiplicity adjustments
  • Preparing Statistical Analysis Plans
  • Preparing Clinical Data Interchange Standards Consortium (CDISC) datasets packages, including legacy data conversion
  • Programming Tables, Listings, and Figures (TLFs) for Clinical Study Reports (CSRs) and other interim reports
  • Providing support for Investigational New Drug application development for drugs and biologics
  • Preparing integrated summaries of safety and efficacy
  • Developing conference presentations and manuscripts
  • Providing statistical support for data monitoring committees
  • Designing data analysis methods for interim and final analyses, such as multivariate modeling of survival/time-to-event and repeated measures/longitudinal analyses, analysis of event rates, meta-analyses, and multiple imputation

Westat’s biostatistical work is performed following our standard operating procedures, providing rigor and credibility and established to comply with industry standards.  Westat has been a proud gold-level member with the CDISC organization since 2017.

View Stephen Black profile

Stephen Black

Manager of Biostatistics

View Walter Faig profile

Walter Faig

Senior Biostatistician

View Jennifer Fulton profile

Jennifer Fulton

Senior Biostatistician

View Deepak Khatry profile

Deepak Khatry

Associate Director and Biostatistics Lead