Software Engineer

• Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications.
• Works to ensure that outputs meet quality standards and project requirements.
• Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings.
• Keeps project team members informed of programming progress and issues requiring their attention.
• Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
• Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness.
• Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload.
• May develop specifications for datasets and outputs according to statistical and Sponsor requirements.
• Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework.
• Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others.
• Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business.
• Completes project programming activities within timeframe allotted by Lead Statistical Programmer and/or management.
• May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables.
• Assists with the transfer of deliverables.
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Statistical Programmer II, R, SAS, SQL

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