Description
* Planning, executing a range of biostatistical activities to support Clinical Development and Medical Affairs* Oversee third party vendors as needed
* Ad hoc analyses of existing databases, meta-analyses, and data mining
* Planning the statistical analyses, programming and execution of the analyses
* Instructing and reviewing third party statistical planning and analysis work
* Provide leadership in development / design of one or more protocols for a specific project and support/participate in the development of clinical program
* Develop statistical analysis plan (SAP), programming specifications, and SAS programing for derived dataset and validate TFLs
* Perform inferential analyses; inputs to the statistical section of the clinical study report (CSR) and review clinical study report. Provide support for the study team to move CSR through the review and approval process. Provide statistical insight into interpretation and discussion of study results.
* Collaborate with project team on the production of the clinical development plan (CDP) and May act as representative to extended project team
* Must have the ability to generate all of the production statistical output and hands on experience with SAS, S-Plus (or R), other software related statistical work
* Produce / coordinate production of statistical summaries, analyses, annual reports, and publication review, preparation of scientific research related materials
* Extensive leadership skills and extensive outsourcing project managing experience with CROs.
If you would be interested in this role please get in contact with Oliver Davies on or connect on LinkedIn https://www.linkedin.com/profile/public-profile-settings?trk=prof-edit-edit-public_profile