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Statistical Programmer II
3 weeks ago
- Working with the Biometrics staff, the candidate will provide programming support for Phase 1 to Phase 3 studies. Providing timely support to the project team on all statistical programming matters according to the project strategy.
- The candidate programs SDTM/ADaM/TLFs for the studies, write datasets specification, QC datasets and tables. Identifying and communicating changes in project requirements that may affect key deliverables.
- Involve in the programming activities on multiple projects/ studies across various therapeutic areas, both internally and externally by CROs.
- Create and review annotated CRF to SDTM datasets.
- Provide support in balancing conflicting priorities, promoting communication and adequate information flow to motivate, encourage and align people with the company's strategic objectives
- Function as a positive role model for setting high expectations for quality, creativity and project ownership
- Works collaboratively with Clinical Operation, Data Management, Global Drug Safety, Regulatory and Project Management management/staff to meet project deliverables and timelines for statistical data analysis and reporting.
- Provide technical input into documents produced by other functions (e.g. biostatisticians, data managers, medical writers.
- Work with Biometrics and other function for the development and maintenance of the data review and reporting tools, and any other statistical applications as appropriate.
- Involved with the strategy for process improvement.
- Identify new tools to increase efficiency and quality.
- Master's Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline.
- Minimum of 1-5 years of clinical trial programming experience in the biotechnology, pharmaceutical or health related industry.
- dvanced SAS programming skills and experience in other statistical software,such as R and S-Plus
- Experience and in-depth knowledge in CDISC including SDTM, ADaM, and controlled terminologies
- Self-directed, technically strong, and a recognized leader maintaining a strategic prospective with regard to statistical programming processes, management of statistical programing projects.
- Excellent organizational skills and ability to prioritize tasks.
