Dyne Therapeutics · 4 months ago
Associate Director, Statistical Programming
Waltham, MA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expDyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. The Associate Director, Statistical Programming will oversee statistical programming activities, ensure compliance with SOPs, and collaborate with cross-functional teams to optimize clinical development processes.
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
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
Bachelor's or advanced degree in statistics, biostatistics, computer science, or a related field
Minimum of 8 years of experience in statistical programming within the pharmaceutical or biotech industry
Proficiency in SAS is essential; experience with Python and R is desirable
Strong knowledge of CDISC standards (SDTM, ADaM) and regulatory requirements for clinical trials
Demonstrated leadership and project management skills, including the ability to lead cross-functional teams
Excellent communication and interpersonal skills
Detail-oriented with a commitment to data accuracy and quality
Ability to adapt to changing priorities and manage multiple projects simultaneously
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 (6)
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
2026-01-07
2025-12-24
MarketScreener
2025-12-24
Company data provided by crunchbase