Lead Biostatistician - Biotech
- Experience Level
Compass Life Sciences have partnered with a growing and exciting Biotechnology company who specialise in rare diseases using the cutting edge science of Gene Therapy. Due to sustained growth and investment, they are looking to grow their Statistical capabilities, and are looking for an experienced Biostatistician to join their modern and state of the art central London offices.
The Senior Biostatistician is a key member of our clients cross-functional clinical team working to provide life changing and transformative gene therapies to patient with rare and often unmet diseases. Reporting into the Director of Biostatistics this position provides a rare opportunity to showcase your statistical expertise across all aspects of clinical drug development, in a dynamic and thoroughly rewarding patient orientated environment.
Lead Statistician of a number of high-profile studies across a range of therapeutic areas
Key member of the Clinical Study Team, providing statistical input across all aspects of clinical studies and submissions, with particular focus on data and statistical quality pertinent to regulatory requirements and scientific validity
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 documentation
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
Response to questions from regulatory authorities
To be considered for this position, our client is looking for passionate Statisticians who are able to demonstrate significant experience working within a commercial environment. In addition to this, you should have;
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
Good knowledge of CDISC standards
Self-starter with the ability to work on a cross-functional team
Experience working in rare diseases or in trials in small populations would be an advantage
Experience with Bayesian methodology would be an advantage
MSc or PhD in a relevant statistical field
Significant experience working within a commercial drug development environment
Proficiency with SAS is essential, and experience with R is advantageous
Strong knowledge of CDISC standards
If you would like to be considered for this position, contact Gareth Hughes-Jones directly on 02392 316 034 for a conversation in confidence. Alternatively email an updated CV to email@example.com.
Compass Associates Ltd is acting as a Recruitment Consultancy for this permanent vacancy; we offer £250 worth of Amazon vouchers for each successful recommendation.