Senior Manager, Statistical Programming

Role Summary

The Senior Manager, Statistical Programming serves as the statistical programming lead for a defined number of clinical studies, with accountability for all study-level statistical programming activities conducted in-house and/or through vendor oversight. This role is the primary point of contact for statistical programming and data standards for assigned studies, providing technical leadership and consultation to cross-functional program teams. The Senior Manager also supports the planning and resourcing of statistical programming activities to ensure timely and high-quality delivery across the Dyne clinical portfolio. This position contributes to departmental strategy, as well as the development and continuous improvement of programming procedures, training, and standards. This is a full-time position based in Waltham, MA.

Responsibilities

• Lead statistical programming for assigned clinical studies, with end-to-end accountability for study-level programming deliverables, quality, timelines, and compliance with regulatory requirements and internal standards
• Oversee and coordinate FSP vendor-based statistical programming resources, including task assignments, progress tracking, issue escalation, and quality oversight
• Plan, manage, and monitor project timelines and deliverables across assigned studies to ensure on-time and high-quality execution in alignment with study milestones and escalate risks as appropriate
• Collaborate closely with biostatisticians, data managers, and cross-functional teams to define and execute effective programming activities and study-specific requirements
• Develop, validate, and maintain analysis datasets (CDISC-compliant SDTM and ADaM), as well as tables, listings, and figures (TLFs), in accordance with regulatory guidelines and internal standards
• Review and provide input on Statistical Analysis Plans (SAPs) to ensure programming assumptions, derivations, and outputs are clearly defined and executable
• Perform or oversee complex statistical programming and analyses using SAS to support clinical trial analyses and data interpretation
• Provide statistical programming expertise to oversee and/or perform activities supporting regulatory submissions (e.g., FDA, EMA), including the preparation of electronic submission components (eCTD), Define.xml, and reviewer guides
• Stay current with industry trends, best practices, and emerging technologies in statistical programming, data standards, and regulatory expectations

Qualifications

• Bachelor's or advanced degree in statistics, biostatistics, computer science, or a related field
• 7+ years of experience in statistical programming within the pharmaceutical or biotech industry
• Proficiency in SAS is essential; experience with R is preferrable
• Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements for clinical trials
• Demonstrated leadership and project management skills, including the ability to collaborate with cross-functional teams
• Excellent written and verbal communication and interpersonal skills
• Detail-oriented with a commitment to data accuracy and quality
• Ability to adapt to changing priorities and manage multiple projects simultaneously