Associate Director, Statistical Programming
Dyne Therapeutics
August 25, 2026
On-site
Waltham, MA
Clinical Research and Development
Role Summary:
The Associate Director, Statistical Programming is accountable for program-specific and cross-study statistical programming activities, including oversight of vendor programming activities. Provides technical leadership across multiple studies within a program, ensures consistency and data standards, and consults study teams.
Primary Responsibilities Include:
- Lead and oversee statistical programming across multiple clinical trials/studies; ensure high-quality deliverables, consistency, and timelines.
- Collaborate with biostatisticians, data managers, clinical operations, vendors, and cross-functional stakeholders to define programming strategies and study requirements.
- Develop, validate, review, and maintain CDISC analysis datasets (SDTM/ADaM) and TLFs per regulatory/internal standards.
- Provide technical leadership/oversight to ensure consistent implementation and standards.
- Review statistical analysis plans (SAPs) and provide strategic/operational input for feasibility, consistency, and regulatory readiness.
- Perform complex analyses and simulations using SAS and/or R; support analytical and data visualization for interpretation and decisions.
- Provide expertise for regulatory submissions (FDA/EMA), including eCTD standards and submission readiness.
- Coordinate/oversee vendor/FSP programming to ensure quality, compliance, and timely delivery.
- Build reusable, software-agnostic tools/macros/automation; improve efficiency and standardization.
- Contribute to departmental standards, processes, validation, and innovation.
- Mentor junior programmers; may supervise small teams/contractors.
- Support resource planning and prioritization.
- Stay current on industry/regulatory best practices and emerging technologies.
Education and Skills Requirements:
- Bachelor’s degree required; advanced degree preferred.
- 10+ years statistical programming experience in pharma/biotech (multi-study preferred).
- Advanced SAS required; R/Python preferred.
- Strong CDISC standards, regulatory submission, and data standards knowledge.
- Experience leading/supporting regulatory submissions (eCTD preferred).
- Vendor/FSP coordination experience preferred.
- Leadership/project management for cross-functional initiatives and multiple priorities.
- Strong clinical development process understanding and collaboration.
- Excellent communication and stakeholder management.
- Detail-oriented; strong commitment to quality/compliance.
- Ability to adapt and contribute to continuous improvement.
Location:
- Waltham, MA
The Associate Director, Statistical Programming is accountable for program-specific and cross-study statistical programming activities, including oversight of vendor programming activities. Provides technical leadership across multiple studies within a program, ensures consistency and data standards, and consults study teams.
Primary Responsibilities Include:
- Lead and oversee statistical programming across multiple clinical trials/studies; ensure high-quality deliverables, consistency, and timelines.
- Collaborate with biostatisticians, data managers, clinical operations, vendors, and cross-functional stakeholders to define programming strategies and study requirements.
- Develop, validate, review, and maintain CDISC analysis datasets (SDTM/ADaM) and TLFs per regulatory/internal standards.
- Provide technical leadership/oversight to ensure consistent implementation and standards.
- Review statistical analysis plans (SAPs) and provide strategic/operational input for feasibility, consistency, and regulatory readiness.
- Perform complex analyses and simulations using SAS and/or R; support analytical and data visualization for interpretation and decisions.
- Provide expertise for regulatory submissions (FDA/EMA), including eCTD standards and submission readiness.
- Coordinate/oversee vendor/FSP programming to ensure quality, compliance, and timely delivery.
- Build reusable, software-agnostic tools/macros/automation; improve efficiency and standardization.
- Contribute to departmental standards, processes, validation, and innovation.
- Mentor junior programmers; may supervise small teams/contractors.
- Support resource planning and prioritization.
- Stay current on industry/regulatory best practices and emerging technologies.
Education and Skills Requirements:
- Bachelor’s degree required; advanced degree preferred.
- 10+ years statistical programming experience in pharma/biotech (multi-study preferred).
- Advanced SAS required; R/Python preferred.
- Strong CDISC standards, regulatory submission, and data standards knowledge.
- Experience leading/supporting regulatory submissions (eCTD preferred).
- Vendor/FSP coordination experience preferred.
- Leadership/project management for cross-functional initiatives and multiple priorities.
- Strong clinical development process understanding and collaboration.
- Excellent communication and stakeholder management.
- Detail-oriented; strong commitment to quality/compliance.
- Ability to adapt and contribute to continuous improvement.
Location:
- Waltham, MA