As the sun is setting on the International Year of Statistics, the need for statistics in the Pharmaceutical, Biotech, and Medical Device industries is rising. Being a clinical trial statistician provides an opportunity to assist with clinical trial design, preparation of analyses, analyzing clinical trial data, interpreting results, writing clinical study reports, and any subsequent regulatory submission activities. Most people at first glance do not realize the many areas where a statistician can play a role in clinical development research and, more importantly, product development.
Having statistical input as soon as pre-clinical studies begin can be very beneficial to help streamline the entire product development life-cycle efficiently.
Here are eight activities where statistical input can be used during the product development life-cycle:
- Pre-clinical Development
- Clinical Development
- Regulatory Submissions (e.g. NDA, PMA, MAA, etc)
- Marketing Studies
- Phase IV/Post-approval studies
- Post-market surveillance
- Product Safety Reviews
There are also additional areas where statistical input can be utilized.
Simulstat Inc, a recognized leader in providing SAS Programming services for clinical development data, is now able to provide statistical support to other areas of the product development life-cycle. For more details into how SimulStat’s statistical programming and consulting services can assist your company, please contact us.