Senior Director, Biostatistics & Regulatory Strategy

Dyne Tx; Waltham (MA); On-site; USD 250,000 - 290,000; Full time

Job summary

Dyne Therapeutics, based in Waltham, MA, seeks a Senior Director, Biostatistics to provide strategic, technical, and operational leadership across one or more clinical programs. You will lead statistical activities from protocol development to regulatory submissions, ensuring scientifically rigorous, innovative strategies aligned with corporate goals.

Ideal candidates will have strong communication, leadership, and cross-functional collaboration skills, with experience in rare disease drug

Qualifications

• PhD or Masters in statistics/biostatistics with extensive pharma/biotech experience.
• Experience leading design, analysis, interpretation, and reporting of clinical trials.
• Experience supporting regulatory submissions and health authority interactions.
• Deep understanding of statistical methodology for clinical development and missing data.
• Strong knowledge of CDISC standards and regulatory guidelines.

Responsibilities

• Serve as the senior biostatistics lead for designated studies and programs.
• Provide strategic input into study design, endpoints, and analysis plans.
• Lead statistical analysis plans and integrated safety/effectiveness summaries.
• Collaborate with cross-functional teams to align statistical strategies with program goals.
• Oversee CROs and external vendors to ensure timely, high-quality outputs.
• Communicate results to leadership, regulators, and external partners.

Skills

Biostatistics leadership

Clinical trial design

Regulatory interactions

Statistical programming (SAS)

Cross-functional collaboration

Education

PhD or MSc in Statistics/Biostatistics

Tools

SAS

R

CDISC SDTM/ADaM

Job description

Dyne Therapeutics, based in Waltham, MA, seeks a Senior Director, Biostatistics to provide strategic, technical, and operational leadership across one or more clinical programs. You will lead statistical activities from protocol development to regulatory submissions, ensuring scientifically rigorous, innovative strategies aligned with corporate goals.

Ideal candidates will have strong communication, leadership, and cross-functional collaboration skills, with experience in rare disease drug