Description

Lead statistical programming for clinical trial safety and efficacy reporting, owning the creation, validation, and maintenance of analysis files, tables, listings, and figures.

This role is on-site.

Responsibilities

• Perform hands-on statistical programming to generate and validate clinical data outputs.
• Implement CDISC SDTM, ADaM, and Define standards for regulatory submissions.
• Lead small team projects and sub-team tasks with minimal supervision.
• Develop specification documents and maintain tracking and validation documentation.
• Collaborate with cross-functional study members in a globally dispersed environment.

Required Skills

• 5+ years of statistical programming experience in a clinical development environment.
• Advanced SAS data manipulation, analysis, and reporting skills.
• Expertise in CDISC SDTM implementation.
• Working knowledge of CDISC ADaM and Define standards.
• Experience with the drug development life cycle and clinical trial data.
• Ability to execute complex programming tasks under challenging timelines.
• Strong oral and written English communication skills.
• Degree in Statistics, Mathematics, Computer Science, Life Sciences, or a related scientific subject.

Key Skills

Education

Any Graduate