Senior Manager, Statistical Programming - Remote

Overview

The Senior Manager of Statistical Programming is responsible for ensuring the integrity, quality, and delivery of statistical analyses across the entire portfolio, leading statistical programming efforts for all compounds and key regulatory submissions.

In Short

• Lead statistical programming and regulatory submission activities.
• Manage CROs to meet timelines and quality expectations.
• Collaborate with functions to ensure clarity and accuracy of CRFs.
• Create and validate SDTM, ADaM, and TLFs.
• Develop complex and reusable Macros for data processing.
• Write and review data specifications for SDTM and ADaM datasets.
• Track clinical trial milestones and vendor deliverables.
• Maintain project records and documentation.
• Understand and perform in accordance with regulatory standards.
• Ensure accuracy of regulatory submission data and reports.

Requirements

• BS in Statistics, Biostatistics, Engineering, or related field with 8+ years of experience.
• Excellent SAS Software Programming skills, including macro development.
• Strong understanding of clinical trial processes and regulatory submission requirements.
• Extensive knowledge of CDISC standards and best practices.
• Experience in defining CDISC compliant SDTM and ADaM data.
• Strong knowledge of FDA & ICH/GCP regulations.

Benefits

• Inclusive and welcoming work environment.
• Equal opportunity employer.
• Opportunity to make a difference in health.
• Work with innovative technology and a dedicated team.
• Professional development opportunities.