Biostatistics and Statistical Programming

We are knowledgeable in a variety of statistical programming software including SAS®, StatXact®, and WinNonLin®. We strive to ensure integrity of your data, organize the results in a clear and compelling presentation, and provide the information needed in a timely manner.

In fact, time from database lock to delivery of verified tables, listings, and figures is generally seven to 10 business days. Top line results can be delivered sooner.

PharPoint provides the following biostatistics and statistical programming services:

• Strategic clinical development consulting
• Protocol development
• Sample size planning and power calculation
• Randomization planning
• Detailed statistical analysis plans including mock tables, listings, and figures
• Statistical support for interim, futility, and DMC analyses
  • DMC support includes assistance with committee composition, preparation of the DMC charter, generation of the analyses, attendance at the meetings, and preparation of the meeting minutes
  • Experience with conditional power, sequential analysis methods, and other specialized statistical techniques
• Collaboration on integrated summaries of safety and efficacy and regulatory submissions including e-submission Item 11 preparation
• Quality output generated and verified using independent programming of all derived data, tables, and listings
• Experience with quantitative epidemiology including patient registries
• Data mining/exploratory analyses
• Regulatory and Advisory meeting support