Biostatistics & Bioinformatics Core

The PTraC BBC will provide biostatistical and bioinformatics consultation in a dynamic, team-fashion approach, from inception, to data planning and sample size/power calculation, to data analysis. The BBC will prioritize grant submissions and NIH reports, though will support development of abstracts, presentations, and manuscripts as well. For abstracts, presentations, and manuscript support, we follow CIDA’s interpretation of ICJME authorship guidelines.

Biostatistics Support:

• Sample size and power calculations
• Clinical trial design and randomization plans
• Grant development, including statistical and computational analysis plans
• Generating data analysis plans for each study hypothesis that is appropriate to the study design and the data set at hand.
• Data analysis spanning from simple cross-sectional analyses, to multi-level modeling, longitudinal analysis, clustering analysis, multivariate analysis, machine learning, etc.
• Assistance with writing protocols, statistical analysis plans (SAPs) for Investigational New Drug Applications (INDs) and the statistical section of the clinical study report (CSR) for New Drug Applications (NDAs) for regulatory purposes
• General study design and data science consultation.
• Reproducible data analysis workflows which can be shared and published alongside publications.

   

Bioinformatics Support:

PTraC (Pulmonary Translational Core) provides bioinformatics support to Pulmonary researchers on various projects requiring substantial computational resources and/or advanced computational techniques. These projects include grant development, publication of manuscripts, and NIH reports, to name a few. Examples of supported workflows are: 

• RNA-seq analysis
• Whole-genome sequencing
• Whole-exome sequencing
• Single-cell sequencing
• ChIP-seq
• Functional genomics
• Analysis and mining of publicly available data
• Pathway and network-based analysis
• Custom bioinformatics analyses

   

For each bioinformatics project, the core will provide:

• Rigorous quality control including a full quality control report of data processing steps
• Storage of data for duration of the analysis
• An initial exploratory analysis report
• A comprehensive final analysis report
• Active communication throughout the project
  

We will support Pulmonary researchers on new grant proposals with the understanding that the proposed grant budgets sufficient FTE (Full Time Equivalent) for biostatistics and bioinformatics. We will help to write the budget justification.

Our process

There are a few steps we take to ensure we have enough information to determine if we are best fit for your data and research. Below is how a typical project navigates its way through the BBC.

• Submit your request, listing the type(s) of biostatistical support sought (data management, data analysis, grant development, or general biostatistical support)
• Meet with us for an initial consult to discuss the details of your project.

For grant development:

• We will assist in developing the study hypotheses, statistical analysis plan(s), and sample size justifications, provided you agree to budget an appropriate amount of time in the grant for biostatistics and informatics.
• We will write the budget justification for biostatistics and informatics.

For data analysis projects:

• Receive our scope of work (SOW) which includes anticipated project costs, details, deadlines, and an analysis sketch
• Begin working with our team once you approve our agreement
• Disseminate your results, keeping in mind the ICMJE guidelines.

Due to the high demand of this core, PTraC BBC has developed a prioritization chart to help investigators understand how their requests for support are prioritized: