Dyne Therapeutics · 10 hours ago
Director, Statistical Programming
Waltham, MA
Full-time
Onsite
Director/Executive
$190K/yr - $233K/yr
12+ years expDyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The Director, Statistical Programming is accountable for in-house statistical programming activities and oversight of related activities by vendors for assigned clinical development programs, ensuring high-quality deliverables and adherence to timelines.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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
Qualification
Required
MS or BS degree in Statistics, Computer Science, Mathematics, Public Health, or related quantitative fields
MS with a minimum of 12 years or BS with a minimum of 14 years of experience in a pharmaceutical industry or other clinical research setting with clinical trials
Highly competent in SAS programming and Macro development; ability to understand the implementation of statistical analyses
Thorough understanding of ICH Guidelines and relevant regulatory requirements and CDISC standards
Familiarity with expectations of regulatory agencies, like FDA, EMA etc
Direct experience with NDA/BLA or other regulatory filing, including ISS or ISE
Experience with departmental resource allocation and labor requirement assessment
Excellent written, verbal, and interpersonal communication skills, and strong negotiation, and organizational skills
Ability to work effectively and efficiently independently and as part of a functional and cross-functional team
Ability to influence without authority
Willing and able to demonstrate agility and flexibility as needed in a small biotech
Ability to work effectively in a highly dynamic and fast-moving environment
Awareness to escalate issues appropriately
Preferred
Preferred knowledge of other programming languages such as R
Direct supervisory experience preferred
Company
Dyne Therapeutics
Dyne Therapeutics is a developer of targeted therapies intended for serious muscle diseases.
51-200 employees
H1B Sponsorship
Dyne Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (7)
2023 (1)
2022 (3)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$1.67BKey Investors
Hercules CapitalAtlas Venture
2025-12-09Post Ipo Equity· $402.5M
2025-06-30Post Ipo Equity· $230M
2025-06-30Post Ipo Debt· $100M
Leadership Team
John Cox
Chief Executive Officer
Recent News
2025-12-24
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2025-12-24
Company data provided by crunchbase