Working in such a highly regulated environment, peer review is such an integral part of my experience as a statistician.

Some work and documents which need peer review are;

• Study design and protocols; does the design fit the objective of the study? what is the hypothesis we will be testing (if applicable)? will enough data be collected? will the right data be collected? and, how will these data be analysed? These are all questions a statistician will be considering when reviewing or designing a study.
• Data Collection Forms; in a regulated environment you will need to consult an experienced data manager to cover data traceability and change control. However what data is collected and the format it is collected in is something which should be reviewed by a statistician.
• Statistical Analysis Plans; depending on the type of study, study design and purpose will determine when a statistical analysis plan will be required and the level of detail needed. It's always necessary to have a high level plan of how to analyse the data and which data you will include in the analysis when you design the study, however a separate document is usually needed to provide sufficient detail of the hypothesis you wish to test and all the supporting analysis that will be completed. It's always good at this stage to think about what you'd like to be able to say when you report the study.
• Analysis Data Sets; as a statistician it is important to look at the data collected and prepare this ready for analysis. Any calculations made should be checked for accuracy, if there is a statistical analysis plan do they conform with the SAP? Are the data complete, does all the data qualify for analysis. If a professional data manager is not available, some data checking can be programmed to provide a review on the quality of the data.
• Statistical Analysis and Summaries;, performing reviewing the analysis which has been completed is also a key role of a statistician. In a regulated environment it is essential to provide assurance the analysis has been performed correctly.
• Interpretation; as a statistician I look at the study design, analysis and wider context to see what evidence we have from our data and what knowledge we have gained. Is the product working and how confident can we be that it is working. And in my main industry of medical devices and pharmaceutical, no analysis is ever complete without considering the safety of the product.
• Publications; I have experience as an author of scientific publications and can support you in the statistical aspects of abstracts, posters, presentations and manuscripts, or simply review advertising material.

Please note: I currently work alone and therefore I can not author and peer review a piece of work. I am happy to collaborate with other professionals or for non-regulated work, I can assume responsibly for the quality of the work. I will always advise you if I feel the work would benefit from further review.