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;
Programming of study analysis, review of study results and preparation of statistical methods section for clinical / statistical reports;
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.
Qualifications
Ph.D. degree in Biostatistics / Statistics / Medical Statistics;
Experience in SAS Programming;
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 preferred.
