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 design
• Support sample size calculations and statistical methodology
• Contribute to protocol synopsis development
• Advise and guide the sponsor throughout study set-up
• Support strategy relating to FDA and European regulatory submissions
• Provide some hands-on SAS programming where required

Your experience:

• Extensive experience as a Statistician within Medical Devices
• Strong knowledge of clinical study design and statistical strategy
• Previous FDA and European submission experience
• Strong SAS skills and ability to perform sample size calculations
• Excellent client-facing and communication skills
• Comfortable 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.