Biostatistics Lead

Your new companyHays have partnered with a growing biotech driving breakthrough innovations in the space of gene therapy who are looking to add a hands-on Biostatistics Lead to their team.The company prides itself on innovation and collaborative work and has a very experienced senior leadership & technical team coupled with a C-suite with a truly impressive track record. They are currently conducting clinical trials and have multiple programmes approaching the clinic, giving them a very strong pipeline.Your new roleThis role will be working closely with the Head of Biostatistics and Programming as well as other senior stakeholders to deliver analysis and interpretation of trial results and further develop internal methodologies and capabilities within biostats.The role is heavily home based with occasional travel to their site in London.Major responsibilities will include (but aren't limited to):

• Carrying out protocol and SAP development, reporting, and data analysis
• Lead on innovative trial design and help develop / implement new methodology or approaches
• Support regulatory submissions and other activities.
• Engage with external boards and represent the company at scientific meetings.
• Collaborate with other departments, eg on trial design, status and any other issues
• Hands-on statistical analyses for clinical trials and potentially other research projects
• Act as a technical expert within the company on statistical analysis (eg around areas such as adaptive trial design, Bayesian or frequentist approaches)

The preference is for a permanent role. However, the company may consider contractors for the right candidate.What you'll need to succeedAs well as strong communication skills for dealing with collaborators and stakeholders you should have:

• Significant technical expertise within statistics, developed from analysing data sets from at least one of: clinical trials, epidemiological, or Real World Evidence data within a CRO, pharmaceutical or biotech organisation
• An MSc / PhD (or equivalent experience) within statistics / biostatistics, data science, epidemiology or a related area
• Experience of analysing data from small patient populations / cohort trials, eg orphan / rare disease, or areas such as ophthalmology, immunological diseases such as Lupus or genetic diseases such as cystic fibrosis
• The ability to express complex statistical ideas and data to non-technical stakeholders and colleagues, eg within the Clinical Operations team
• A track record of working on projects both independently and as part of a wider team
• An interest in applying and developing new approaches to statistical analysis and interpretation of data

A 'nice to have' is experience of supervising / leading staff but this is not a pre-requisite for the role.There is a significant preference for this person to be UK based.What you'll get in returnYou'll get the chance to make a significant impact on the company's clinical development projects, taking on project leadership for a number of different aspects, and drive forward the assets they have within their pipeline.The company are very flexible on salary bands and package depending on the skills of the person coming in and you will be a key member of a highly experienced team, with direct access to the C-suite leadership.What 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 me on .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, especially as there are a number of other bioinformatics, data science and statistics positions available.

Keywords: clinical, data, statistics, statistician, trial, Bayesian, adaptive, design, frequentist, machine, learning, ML, model, HTA, RWE, epidemiology, rare, disease, genetic, ophthalmology, lead, principal, cohort, pharmaceutical, biotech, drug, development