A consulting biostatistician in the pharma/medtech industry is always juggling multiple projects which could all have very different needs. However there are some tasks that are common to all such projects:
- Understanding the pipeline strategy and objectives of a clinical trial and ensuring that these are aligned with the proposed intended use, patient population, regulatory requirements and potential market access burden.
- Analysis of existing data or meta data for establishing sample size and/or informative priors for a Bayesian design.
- Identifying risks for an under or over powered study and putting risk mitigation strategies into place such as through Adaptive Design.
- Writing a statistical planning document for complex innovative design helps not only in communicating the details of the design to regulatory bodies but also this document serves as source for other documents such as study protocol, statistical analysis plan (SAP) and interim charters. Typically for simulation-guided designs this document would include simulation details and results.
- Often the regulatory bodies would require access to simulation programs and files which could be achieved by deploying a web based app (like a R Shiny app) on a secured hosting site.
- Regular communication with the clients perhaps using slide decks or report. This is also applicable when the trial is ongoing in terms of regular safety reports and blinded or unblinded interim analysis reports.
- Writing statistical reports, articles for peer-reviewed journals, technical reports and posters or presentations for congresses.
In this series of short posts, I will be posting about different open-source programs that can be used to achieve efficiency, reproducibility and organization in a biostatistician’s workflow.