IT Elite Inc is looking for an experienced Senior Principal Statistical Programmer- Standards to support the team’s clinical trial data analysis and reporting for a 12+ month and ongoing projects.

QUALIFICATIONS & REQUIREMENTS:

• Bachelor’s degree or equivalent and a minimum of 8-10+ years SAS programming experience in the pharmaceutical/biotech industry is required.
• 12+ years experience preferred.

LOCATION: Work will be performed remotely. This role is fully remote.

This consultant must have strong CDISC knowledge and expertise, specifically ADaM programming and TLG skills, and must be comfortable interpreting specifications.

• Contributes to Analysis Planning and Reporting standardization activities and departmental initiatives.
• Works with-in the Global Clinical Data Standards team in collaboration with each data state: Data Collection, SDTM and ADaM on Analysis Planning and Reporting standardization activities and departmental initiatives.
• Collaborate cross-functionally with Macro team, Biostatistics, Statistical Programming, Medical Writing, and Clinical Development as needed.
• Successfully interacts within Clinical Data Science, with Clinical Development, Patient Safety and Regulatory Affairs groups on a frequent basis.
• Expert knowledge of analysis planning and reporting standards – which includes the Statistical Analysis Plan (SAP) template, Tables, Figures, and Listings (TFLs) shells and submission requirements.
• Develop, review, maintain, and align new and current Sponsor analysis planning and reporting standards to Regulatory Agency submission requirements, CDISC TAUGS, and CDISC standards.
• Review Data Collection, SDTM and ADaM standards for updates and impacts on current Standard TFL shells.
• Serve as a subject matter expert on Sponsor’s reporting standards and related tools/applications, such as STARS. Maintains requirements and documentations for these tools/applications.
• Develop, review, and maintain documentation and training related to analysis planning and reporting standards processes and tools
• Biostatisticians and Statistical programmers work collaboratively with internal colleagues and external vendors to ensure the efficient, high-quality production of analysis datasets and statistical outputs for study reports and integrated summaries in support of Sponsor's regulatory, scientific and business objectives.
If your skills match the above requirement, please forward your resume as a word attachment along with your salary requirements and contact information.