Senior Manager, Statistical Programming

This leadership role oversees statistical programming operations, serving as a bridge between biostatistics and clinical data management. The position involves hands-on SAS/R implementation and quality oversight of both internal and outsourced deliverables.

Key Responsibilities

• Lead programming teams on study-level deliverables in collaboration with statistics leads
• Review statistical analysis plans, data presentation plans, and table shells for alignment
• Produce and validate SDTM, ADaM, and TLF outputs for regulatory submissions and analyses
• Manage CROs and contractors for compliance, quality, timelines, and budget
• Collaborate with biostatisticians on specifications and database accuracy
• Develop global tools and macros to enhance team efficiency
• Manage define.xml development and NDA eSubmission packages
• Assist in building the statistical computing environment platform

Required Qualifications

• Master's degree in Statistics, Biostatistics, Mathematics, or related field
• Minimum 6 years pharmaceutical/biotech clinical trial programming experience
• Advanced SAS skills with extensive SDTM, ADaM, TLF expertise
• Proficiency in CDISC standards and regulatory requirements
• Knowledge of drug development, study design, and statistical methodology
• Experience managing outsourced programming activities
• Strong communication and cross-functional collaboration abilities