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.
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) data 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.
Featured Therapeutic Areas
Related Team Members
Manager of Biostatistics
Associate Director and Biostatistics Lead