Senior Manager, Statistical Programming

Dyne Therapeutics • Waltham, MA

1d • Onsite

About The Position

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn and Facebook.
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.

Requirements

• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level