Principal Biostatistician (FSP)
Office or home based
Join an industry-changing company that is reinventing the way we develop and commercialize drugs. At INC Research/inVentiv Health our 22,000 employees have one purpose: shortening the distance from lab to life. You'll work alongside the brightest minds to create better, faster, smarter processes to speed therapies to patients that need them the most. In fact, in a recent five-year period, INC Research/inVentiv Health has helped to develop or commercialize at least 82% of novel new drugs approved by the FDA and at least 70% of products granted marketing authorization by the EMA.
Within this role you will be part of a client dedicated team, working on Consumer Health trials only. The position is responsible to act as Project Lead on assigned trials and to be main point of contact for the client.
* Act as the core project team lead to coordinate and manage all statistical project activities.
* Provide statistical liaison with the client.
* Provide statistical input for protocol and CRF development.
* Prepare statistical analysis plans.
* Perform validation and statistical quality checks on computer-generated output to verify accuracy.
* Review works performed by others and provide recommendations for improvement.
* Prepare and review key portions of the integrated clinical/statistical report, including sections related to data handling and statistical methodology, patient accountability, baseline comparability, and efficacy and safety results.
* Attend regulatory agency meetings and respond to questions to support the statistical analysis results of clinical trials on behalf of the sponsor.
* Undertake statistical consultancy for sponsor companies.
* Follow departmental SOPS, OGs and relevant regulatory guidelines (e.g. ICH).
* Extensive experience in statistical analysis of clinical or consumer health trials as demonstrated by the ability to lead multiple complex and/or global projects with teams of statisticians
* Strong statistical skills as evidenced by participation in publications or presentations in areas relevant to clinical trial design and analysis
* Proficiency in SAS Programming
* Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
* Ability to travel may be required
Graduate Degree in Statistics or related discipline
In return we will offer:
* A competitive remuneration package with excellent benefits.
* A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization.
* The opportunity to work within a successful and rewarding environment.