Highly innovative working environment, Tremendous work/life balance, Renowned progression opportunities Your new companyHAYS have partnered with a truly specialist biometrics focused CRO who are recruiting for multiple Principal Statisticians. The business are undergoing tremendous expansion plans throughout their Statistical Programming and Biostatistics teams due to floods of investment, continuous expansion within current clients and onboarding of new clients. As a company, they pride themselves on their reputation within two areas, first and foremost for their staff retention and development rates being the highest for any Statisticians within the CRO industry. Secondly, their reputation within their clients to deliver high quality Biometrics services and becoming the go to CRO for a plethora of small to large Pharma's and Biotech's.Your new role
- Provide expert leadership to internal and external study teams in the reporting of clinical trials data, regulatory submissions, safety updates and publications.
- Act as lead statistician for multiple projects with any level of complexity.
- Collaborate in the process of protocol development by choosing an appropriate study design, including statistical methodologies, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol.
- Act as the POC with the sponsor for all statistics related activities on assigned projects.
- Perform statistical review of relevant study documentation (i.e. case report form, randomisation specification) and clinical study reports.
- Author and review Statistical Analysis Plans (SAPs) based on the protocol, including development of output shells for tables, figures and listings.
- Statistical review of dataset specifications.
- Programming and validation of efficacy analysis datasets and associated tables, figures and listings.
- Participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development.
- Prepare key portions of the integrated clinical/statistical report, ISS and ISE, including sections related to data handling and statistical methodology, patient accountability, baseline compatibility, and efficacy results.
- Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
What you'll need to succeed
- Proven background as a Statistician within the CRO, Pharmaceutical, Medical Device or Biotech industry
- Excellent communication skillset
- Excellent analytical skillset
- Full right to work in the UK
What you'll get in returnWhat you need to do nowIf you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.