BioStat Solutions, Inc. (BSSI) provides innovative expert-level statistical analysis and strategic consulting to the pharmaceutical and biotech industries as well as to the US Government. BSSI has its roots in the National Cancer Institute, where its President and CSO did her post-doctoral training. BSSI was established in 2001 based on the need for statisticians and clinical investigators to be able to communicate effectively in order to make smart decisions in the analyses and interpretation of clinical studies.
BSSI’s Precision Statistics® approach provides the client with an individualized approach where statistical analyses tools are carefully matched to the research needs and business objectives of the client. In this approach, our statisticians function as a team to provide relevant information to our clients and assist in the interpretation of statistical findings that helps answer the “so-what” question. Unlike typical Clinical Research Organizations (CROs), BSSI provides access to a pool of highly experienced statisticians, geneticists and epidemiologists, using a composite FTE (Full Time Equivalent) model, thereby making sure the right expertise is available for each individual project. Statistics by itself is merely a tool. Thorough background knowledge in most disease areas and experience with virtually every data type guarantees for a quick project start and no time wasted with “getting the statistician up to speed”.
Whether a client is working with novel data (e.g. Next-Generation Sequencing data) in the precision medicine arena or entering new regulatory terrain (e.g. licensure under the FDA Animal Rule), innovative strategies are required to help navigate these challenges. BSSI’s Precision Statistics® approach supports clients towards developing the right study design, and implementing the appropriate analytical approach, with validated analyses appropriate for regulatory submission. In other words, The Right Analysis using the Right Tools for the Right Data.