Senior Statistical Programming Lead for Regulatory Submissions

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

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