Associate Director, Statistical Programming

Company Overview:

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 and follow us on X LinkedInand Facebook.

Company Overview:

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 myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD) and 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.

Role Summary:

The Associate Director Statistical Programming is accountable for program-specific and cross-study statistical programming activities including oversight of vendor programming collaboration with cross-functional stakeholders this position contributes to process optimization innovation and consistency across studies. This position provides technical leadership for statistical programming activities across multiple studies within a program including oversight of vendor-related activities and implementation of data collaboration with cross-functional stakeholders this role provides technical consultation to study teams and supports alignment of statistical programming resources and capabilities to meet organizational priorities. This role assists the Head of Statistical Programming in contributing to departmental strategies and driving the continuous improvement of departmental procedures training standards and automation initiatives.

This role is based in Waltham MA.

Primary Responsibilities Include:

• Lead and oversee statistical programming activities across multiple clinical trials and studies ensuring high-quality deliverables operational consistency and adherence to timelines
• Collaborate with biostatisticians data managers clinical operations vendors and other cross-functional stakeholders to define programming strategies priorities and study requirements
• Develop validate review and maintain analysis datasets (CDISC standards) tables listings and figures (TLFs) in accordance with regulatory guidelines internal standards and submission requirements
• Provide technical leadership and oversight for statistical programming deliverables across studies including consistency of implementation and standards application.
• Review statistical analysis plans (SAPs) and provide strategic and operational input to support execution feasibility cross-study consistency and regulatory readiness
• Perform complex statistical analyses and simulations using SAS and/or R and support advanced analytical and data visualization solutions for clinical trial interpretation and decision-making
• Provide expertise in statistical programming for regulatory submissions (e.g. FDA EMA) including electronic submission standards (eCTD) and oversee submission readiness activities across studies
• Coordinate and oversee vendor/FSP statistical programming activities across studies to ensure quality compliance and timely delivery
• Build maintain and promote reusable software-agnostic tools macros and automation solutions to improve efficiency scalability and standardization
• Contribute to the evolution and implementation of departmental programming standards processes validation practices and innovation initiatives
• Mentor and provide technical guidance to junior programmers and may supervise or lead small programming teams or contractors
• Support resource planning prioritization and coordination of programming deliverables across studies and programs
• Stay current with industry trends best practices regulatory expectations and emerging technologies in statistical programming and data analysis

Education Experience and Skills Requirements:

• Bachelors degree required; advanced degree preferred in statistics biostatistics computer science life sciences or a related field
• Minimum of 10 years of statistical programming experience within the pharmaceutical biotechnology including multi-study experience
• Advanced proficiency in SAS required; experience with R Python preferred.
• Strong knowledge and applied experience with CDISC standards (SDTM ADaM) regulatory submission requirements and data standards
• Demonstrated experience supporting or leading regulatory submissions including eCTD deliverables
• Experience coordinating vendor/FSP statistical programming activities across multiple studies preferred
• Demonstrated leadership and project management skills including the ability to lead cross-functional initiatives and manage multiple priorities simultaneously
• Strong understanding of the clinical development process and cross-functional collaboration with Biostatistics Data Management and Clinical Development organizations
• Excellent communication interpersonal and stakeholder management skills
• Detail-oriented with strong commitment to quality compliance consistency and operational excellence
• Ability to adapt to changing priorities and contribute to departmental strategy innovation and continuous improvement initiatives

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The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education experience job-related knowledge and demonstrated skills.

The statements contained herein reflect general details as necessary to describe the principles functions for this job the level of knowledge and skill typically required and the scope of responsibility but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned including work in other functional areas to cover absences or relief to equalize peak work periods or otherwise balance workload.

Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age color disability gender national origin race religion sexual orientation veteran status or any classification protected by federal state or local law.