almost 2 years ago
The role includes the completion of clinical trials, to both the assigned time frames and appropriate quality standard, as well as presenting the results at conferences and external non-study meetings. Alongside leveraging local regulatory and therapeutic expertise across areas such as oncology, cardiology, metabolic disease, central nervous system, anti-viral and anti-infective.
*Contribution to clinical development of plan preparation
*Develop detailed data analysis plans for various projects
*Programming of study analysis, including review of results and preparation of statistical methods for reporting.
*Communication of project requirements for CRF design, database clean-up and design, ensuring the key variables are suitable for analysis.
*Communicate clearly statistical results to medical writing personnel to ensure an accurate interpretation of key findings.
*Ph.D. Biostatistics/ Statistics, with strong experience in SAS programming or equivalent.
*Knowledge of advanced statistical methods and regulatory requirements/guidelines for drug development.
*Knowledge of pharmaceutical industry
*Previous experience working in a pharmaceutical or CRO setting is desirable.