Director, Statistical Programming

Overview

Our commitment to people with neuromuscular diseases

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. Learn more https : / / www.dyne-tx.com / and follow us on X, LinkedIn and Facebook.

Role Summary :

The Director, Statistical Programming is accountable for in-house statistical programming activities and oversight of related activities by vendors for assigned clinical development programs. In collaboration with functional line management and cross functional stakeholders, this position contributes to the process optimization and innovation for clinical development. This position serves as an in-house expert for statistical programing and data standards, and assists the team to develop functional strategies and drives the development and continuous improvement of departmental procedures, training and standards.

Primary Responsibilities Include

• Lead and manage the statistical programming activities for clinical trials and studies, ensuring high-quality deliverables and adherence to timelines
• Collaborate with biostatisticians, data managers, and cross-functional teams to define programming strategies and requirements
• Develop, validate, and maintain analysis datasets (CDISC standards), tables, listings, and figures, TLFs in accordance with regulatory guidelines and internal standards
• Review statistical analysis plans (SAPs) to provide feedback and strategy to the team to execute the plans
• Perform complex statistical analyses and simulations using SAS, and R, to support clinical trial design and data interpretation
• Provide expertise in statistical programming for regulatory submissions (e.g., FDA, EMA), including electronic submission standards (eCTD)
• Build and maintain software agnostic solutions / macros to automate repetitive tasks.
• Provide novel solutions to the Biometrics and cross-functional teams to better understand the data
• Manage, mentor and provide guidance to junior programmers, ensuring their growth and development within the team
• Stay current with industry trends, best practices, and emerging technologies in statistical programming and data analysis

Education and Skills Requirements

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.

This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.

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.

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