Associate Director, Statistical Programming

BioSpace; Waltham (MA); On-site; USD 175,000 - 204,000; Full time

Job summary

Dyne Therapeutics in Waltham, MA is seeking an Associate Director, Statistical Programming to lead program-specific and cross-study statistical programming activities, oversee vendor programming, and drive innovation and standardization. This role collaborates with biostatistics, data management, clinical operations, and vendors to ensure timely, high-quality deliverables and regulatory readiness.

Based in Waltham, the role reports to Head of Statistical Programming; requires 10+ years in

Qualifications

• Bachelor’s degree in statistics, biostatistics, computer science, life sciences, or related field
• Minimum of 10 years in statistical programming within pharma/biotech, including multi-study
• Proficiency in SAS; knowledge of R/Python preferred
• Strong CDISC SDTM/ADaM and regulatory submission experience (eCTD)
• Leadership and vendor coordination experience

Responsibilities

• Lead and oversee statistical programming across multiple trials ensuring quality and timelines
• Collaborate with statisticians, data managers, clinical operations, vendors and stakeholders to define programming strategies
• Develop, validate, and maintain SDTM/ADaM datasets, tables, listings and figures per regulatory standards
• Provide technical leadership for programming deliverables and ensure cross-study consistency
• Review SAPs and provide input for feasibility and readiness
• Perform complex analyses and simulations using SAS and/or R; support data visualization
• Support regulatory submissions including eCTD readiness across studies
• Coordinate vendor/FSP programming activities across studies
• Build reusable tools and automation to improve efficiency and standardization
• Mentor junior programmers and lead small teams as needed
• Support resource planning and prioritization across studies
• Stay current with industry trends and regulatory expectations

Skills

SAS

R

Python

CDISC SDTM

CDISC ADaM

eCTD familiarity

Regulatory submissions

Vendor management

Leadership

Project management

Education

Bachelor’s degree

Advanced degree preferred

Job description

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

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

• 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 and Skills Requirements

• Bachelor’s 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

Pay Range

MA Pay Range

$175,000 - $204,000 USD

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.