Contract Statistician - Medical Devices

Contract Statistician | Medical Devices | Remote UK & Europe | Day Rate | We are looking for a highly experienced Contract Statistician with strong Medical Device expertise to support a confidential client on a short-term clinical development project. This is a senior, client-facing consultancy opportunity where you will work directly with the sponsor to help develop and finalise the clinical strategy and statistical approach for an upcoming study. What you will be doing:Provide expert statistical input into clinical strategy and study designSupport sample size calculations and statistical methodologyContribute to protocol synopsis developmentAdvise and guide the sponsor throughout study set-upSupport strategy relating to FDA and European regulatory submissionsProvide some hands-on SAS programming where required Your experience:Extensive experience as a Statistician within Medical DevicesStrong knowledge of clinical study design and statistical strategyPrevious FDA and European submission experienceStrong SAS skills and ability to perform sample size calculationsExcellent client-facing and communication skillsComfortable working independently in a senior advisory/consulting capacity The opportunity: This is a fully remote contract, paid on a day-rate basis. The workload will be flexible and will evolve depending on the needs of the project. Initially, we anticipate approximately 8-12 days of consultancy support, after which the Statistician will continue to provide ad hoc support as the project progresses. There is also the potential for additional days and a greater level of ongoing involvement depending on project requirements. Due to the confidential nature of the project, further client information will be provided following the appropriate NDA process.