Senior Statistical Data Specialist

We are seeking a skilled Data Analyst with expertise in statistical programming to support clinical trial data analysis and regulatory submissions.

Key Responsibilities :

• Author, validate, and document code for datasets, transforms, and macros, applying good programming practices.
• Develop and maintain programs in R, with hands-on experience in packages such as Tidyverse and Admiral.
• Create ADaM datasets using Admiral packages in R.
• Read and write raw data across platforms.
• Conduct thorough debugging using console tools.
• Review and approve clinical trial documents, dataset specifications, and transform shells.
• Identify and resolve data issues, outliers, and standards-related discrepancies.
• Complete, review, and approve validation tool reports.
• Stay updated on emerging CDISC standards and assess impacts on ongoing and future trials.
• Maintain proficiency in statistical programming and awareness of developments in programming tools and standards.
• Ensure all study master file documents are audit-ready.
• Serve as Lead Analyst on client accounts and projects, managing client expectations and providing issue resolution.
• Provide input into and review of project management documents.
• Perform all work in full compliance with applicable legislation, regulations, company policies, and procedures.
• Actively contribute to internal and client study team meetings.

Qualifications & Skills :

Preferred Experience :