Associate Director, Statistical Programming

Department: 1220GL - Data AnalyticsLocation: Waltham, MACompany 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 preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at, and follow us onX,LinkedInandFacebook.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 activities. In 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 standards. In 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 timelinesCollaborate with biostatisticians, data managers, clinical operations, vendors, and other cross-functional stakeholders to define programming strategies, priorities, and study requirementsDevelop, validate, review, and maintain analysis datasets (CDISC standards), tables, listings, and figures (TLFs) in accordance with regulatory guidelines, internal standards, and submission requirementsProvide 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 readinessPerform complex statistical analyses and simulations using SAS and/or R and support advanced analytical and data visualization solutions for clinical trial interpretation and decision-makingProvide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD), and oversee submission readiness activities across studiesCoordinate and oversee vendor/FSP statistical programming activities across studies to ensure quality, compliance, and timely deliveryBuild, maintain, and promote reusable, software-agnostic tools, macros, and automation solutions to improve efficiency, scalability, and standardizationContribute to the evolution and implementation of departmental programming standards, processes, validation practices, and innovation initiativesMentor and provide technical guidance to junior programmers and may supervise or lead small programming teams or contractorsSupport resource planning, prioritization, and coordination of programming deliverables across studies and programsStay current with industry trends, best practices, regulatory expectations, and emerging technologies in statistical programming and data analysisEducation and Skills Requirements:Bachelor’s degree required; advanced degree preferred in statistics, biostatistics, computer science, life sciences, or a related fieldMinimum of 10 years of statistical programming experience within the pharmaceutical, biotechnology, including multi-study experienceAdvanced proficiency in SAS required; experience with R, Python preferred.Strong knowledge and applied experience with CDISC standards (SDTM, ADaM), regulatory submission requirements, and data standardsDemonstrated experience supporting or leading regulatory submissions, including eCTD deliverablesExperience coordinating vendor/FSP statistical programming activities across multiple studies preferredDemonstrated leadership and project management skills, including the ability to lead cross-functional initiatives and manage multiple priorities simultaneouslyStrong understanding of the clinical development process and cross-functional collaboration with Biostatistics, Data Management and Clinical Development organizationsExcellent communication, interpersonal, and stakeholder management skillsDetail-oriented with strong commitment to quality, compliance, consistency, and operational excellenceAbility to adapt to changing priorities and contribute to departmental strategy, innovation, and continuous improvement initiatives#LI-OnsiteMA Pay Range$175,000—$204,000 USDThe 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.BACK | NEXT Dyne Therapeutics Inc