Job Description

Rapport Therapeutics seeks a Senior Manager/Associate Director of Statistical Programming to lead clinical trial programming activities across the Bipolar Mania program. The role involves overseeing SAS programming deliverables, managing CRO partnerships, and ensuring regulatory compliance throughout clinical development stages.

Responsibilities

• Lead statistical programming activities from protocol development through clinical study reports and regulatory submissions
• Develop, validate, and document SAS programs for datasets and table/figure/listing outputs
• Manage outsourcing strategy and oversee CRO and external vendor performance
• Ensure compliance with CDISC, ICH, and FDA/EMA standards and company procedures
• Collaborate with Biostatistics leadership and mentor statistical programmers across all levels

Requirements

• Master's or Bachelor's degree in Computer Science, Statistics, Mathematics, or related field
• 8-10 years statistical programming experience in biotech, pharmaceutical, or CRO settings
• Expertise in SAS programming for SDTM, ADaM, and TFL outputs
• Knowledge of CDISC standards, ICH guidelines, and FDA/EMA regulatory requirements
• Experience managing outsourced vendors and CRO deliverables
• Proficiency with clinical trial documentation including protocols, eCRFs, and SAPs

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