Senior / Principal Study Statistician - Gene Therapy - Biotech - London

Senior / Principal Study Statistician – Gene Therapy – Biotech – London - £65k-£90k + bonus

I have recently partnered with a SME, innovative biotech. They are looking for an exceptional study statistician to join their growing team, to be fully home based in the UK, with occasional visits into the office which is based in London.

The Study Statistician is a key member of a cross-functional team working to provide transformative gene therapies to patients with rare diseases. Reporting to the Senior Director Biostatistics, this role provides a unique opportunity to contribute your statistical expertise to all aspects of clinical drug development in a dynamic environment that would suit someone coming from a CRO background.

Responsibilities

In this role you will be expected to take on the responsibilities of the lead statistician for several studies. As a key member of the Clinical Study Team, you will be required to provide input to all statistical aspects of clinical studies and submissions paying regard to data and statistical quality, relevance to regulatory requirements, and scientific validity.

Key responsibilities will include:

• Statistical input into protocol development including advice on study design and writing the statistical section of the protocol.
• Review of CRFs and all data management documents.
• Writing and/or reviewing Statistical Analysis Plans including design of table shells
• Oversight of preparation of statistical outputs including interpretation of results of statistical analyses.
• Statistical input into CSRs and submission documents including preparation of statistical methods and results sections incorporating statistical conclusions.
• CRO oversight
• Response to questions from regulatory authorities

Requirements:

• Expertise in a range of statistical methodologies with practical applications
• Ability to communicate complex statistical concepts to non-statisticians.
• Demonstrable project management and interpersonal skills
• Basic knowledge of CDISC standards
• Self-starter with the ability to work on a cross-functional team.
• Ability to work on lots of ad-hoc hands-on requests.
• Experience working in rare diseases or in trials in small populations would be an advantage.
• Experience with Bayesian methodology would be an advantage but not essential.

Education & skills

• MSc or PhD in statistics or related discipline
• Solid experience working as a statistician in drug development.
• Proficiency with SAS required experience with R an advantage.
• Basic knowledge of CDISC standards
• Excellent communication skills
• Submissions helpful – they are working towards submissions.
• Collaboration
• Would benefit a person coming from a CRO background.

What you get in return:

• To work for an innovative, inclusive biotech, working in leading edge studies around gene therapy within rare disease
• Work in unusual disease areas
• Work with small management team
• Opportunity to be mentored by smart, impressive people.

What to do next:

If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the new Statistician onboard as soon as possible.

Not what you’re looking for? Please contact Aimee Weston at aimee@warmanobrien.com for a confidential discussion about potential opportunities.