Job Description

Job Description:

• 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.

Responsibilities:

• 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

Requirements:

• Master's Degree in Statistics, Computer Science, Mathematics, Engineering or related discipline.
• Minimum of 4-7 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 regarding statistical programming processes, management of statistical programming projects.
• Excellent organizational skills and ability to prioritize tasks.

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