Description
JOB RESPONSIBILITIES:* Support/participate in the development of clinical program
* Review protocols and CRFs for soundness of trial design
* Programming for developing statistical analysis outputs and validate TFLs
* Perform inferential analyses; inputs to the statistical section of the clinical study report and review the publication manuscript and slides for all therapeutic area
* Support/participate in project related activities including oversee CR0 deliverables for studies contracted out
* Act as liaison to study team, ensuring that the clinical study is conducted in a manner that supports planned statistical analysis. With some supervision and guidance from senior departmental staff, design clinical study and help produce protocol or amendments. Perform relevant sample size calculations
* Provide statistical insight into interpretation and discussion of study results
* Produce / coordinate production of statistical summaries, analyses, annual reports, and related materials for submission to regulatory authorities or independent monitoring committees
JOB REQUIREMENTS:
Education
* Ph.D. or MS degree in statistics or biostatistics field
Experience
* At least 5 years of biopharmaceutical experience are required
To find out more about Real please visit www.realstaffing.com