Dedicated to transforming the lives of patients with inherited diseases through innovative gene therapy.
What you'll be doing
- Statistical input into protocol development including advice on study design and writing the statistical section of the protocol.
- Reviewing 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
- Response to questions from regulatory authorities
- 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 statistics or related discipline
- Solid experience working as a statistician in drug development
- Work from home opportunities
- Health insurance
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