Responsibilities
: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(eg 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.Requirements: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.Advanced 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
