With an extensive pipeline of specialist candidate coming through and a co-licensed marketed product, our biotech client has done exceptionally well given their relatively young age. Publicly-listed on global exchanges we've had an excellent relationship with our client in the U.S and Europe for many years.
With large growth plans for the U.S this biotech is looking for a Head of Bioinformatics now who is capable of working directly with the team on the ground in Maryland.
The role
> Oversee relevant requirements around statistical support
> Review animal/research studies providing statistical input around relevant sample sizes
> Review important reports and qualification experiments requiring statistical analysis/assessments
> Assist QA & Regulatory teams on statistical modelling/assessments
> Provide input into the design of the ongoing clinical trials
> Identify issues for clin dev programs and related trials
> Provide statistical expertise as required by the wider teams, performing review of statistical protocols
- therefore having a solid understanding of case report forms (CRFs); clinical study reports (CSRs) and associated tables, listings, and figures (TLFs), Investigator’s Brochures (IBs); scientific manuscripts; and research studies
> Manage stats vendors, involving management of budgets, contracts and quality
> Act as primary signatory, overseeing the development of Statistical Analysis Plans & associated mock shells for protocols
> Act as point of contact representing the client at Data Safety Monitoring Board & SMC meetings as well as investigator meetings and global conferences/presentations
Important qualifications required:
>Advanced degree in statistics is required and/or 2 decades of relevant experience
> Competent in SAS, and relevant regulatory filing systems
> Familiar with prophylactic vaccine and/or immune-oncology trial designs and toxicology studies
Interested, or perhaps you know somebody? Contact Rhys Rowberry on 716-226-1610
