- As a principal project programmer, lead a team of programmers located in different locations and distribute work packages accordingly. Monitor implementation of the work packages and train assigned programmers in the programming concept. Implement documentation and tracking tools.
- Provide support for the electronic submission to regulatory agencies worldwide. This may include the preparation of TMCP analyses or safety and efficacy analyses datasets, data files, application programs, and electronic documentation and user manuals. Perform validation to confirm the quality of the submission.
- Review and provide feedback to the project statistician regarding the scientific portion of the statistical analyses plan and the shell mock-ups for completeness, correctness and adherence to cited department guidelines and SOPs.
- With a Master of Science in the preferred degrees (but not limited to) Bio-/Applied -/ Statistics, Math and Computer Science, minimum of 8 years of statistical programming experience is required within the pharmaceutical industry, CROs or medical devices is required.
- Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming.
- Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials.
- Having knowledge of all phases of drug development, including R&D, early and late clinical development and submission
- Solid knowledge of new advanced statistical methods using R and SAS