about 1 year ago
This role is responsible for Biostatistics activities for clinical trial projects;
to ensure that work is completed within the defined time frames to appropriate quality levels and present the Biostatistics function at conferences and external non-study meetings.
Programming of study analysis, review of study results and preparation of statistical methods section for clinical / statistical reports;
Contribute to clinical development of plan preparation;
Review of study protocol and preparation of statistical methodologies;
Development of detailed Data Analysis Plan for assigned projects;
Communicate project requirements for CRF design, database design and database clean-up to ensure the key study variables are suitable for analysis; and
Communicate statistical results to medical writing personnel to ensure accurate interpretation.
Ph.D. degree in Biostatistics / Statistics with strong experience in SAS Programming or equivalent;
Knowledge of advanced statistical methods and knowledge of the pharmaceutical industry;
Knowledge of regulatory requirements/guidelines for drug development; and
Previous experience in a pharmaceutical or CRO setting desirable.
Join a team dedicated to supporting the development of ground-breaking drugs and devices and help provide hope for those living with debilitating diseases.