Executive Biostatistics Lead, Medical Affairs

Dyne Therapeutics, Inc.; Waltham (MA); On-site; USD 265,000 - 300,000; Full time

Job summary

Dyne Therapeutics, Inc. in Waltham, MA, seeks a Senior Director of Medical Affairs Biostatistics to provide strategic, technical, and operational leadership of biostatistics across evidence-generation activities.

This role partners with Medical Affairs leadership and will shape statistically rigorous evidence strategies to support scientific communication, payer needs, and lifecycle planning. The incumbent will lead Phase IV studies, real-world evidence, and observational research; oversee

Qualifications

• PhD in Statistics, Biostatistics, or a related quantitative discipline with 10+ years of relevant industry experience.
• Experience leading design, analysis, interpretation, and reporting of analyses within Medical Affairs.
• Experience with publications, congress presentations, investigator-sponsored research.
• Strong expertise in observational and real-world research methodologies.
• Advanced SAS programming skills; familiarity with R preferred.
• Experience overseeing CROs, consultants, and external vendors.
• Ability to mentor statisticians and lead in a matrix environment.
• Excellent communication to technical and non-technical audiences.
• Experience in rare disease, preferably neuromuscular disease, preferred.

Responsibilities

• Provide strategic leadership for statistical activities across Medical Affairs evidence-generation initiatives.
• Lead design and execution of Phase IV, observational, registry, and real-world studies.
• Oversee secondary and exploratory analyses to support publications and payer evidence.
• Guide PRO/HRQoL analysis and endpoints interpretation for publications and dossiers.
• Lead statistical strategy for Medical Affairs publications and external communications.
• Manage CROs and vendors with scope, quality, and timelines.

Skills

SAS programming

Observational methods

Real-world evidence

CRO oversight

Communication skills

Statistical leadership

Education

PhD in Statistics/Biostatistics

MS with 12+ years experience

Tools

SAS

R

Job description

Dyne Therapeutics, Inc. in Waltham, MA, seeks a Senior Director of Medical Affairs Biostatistics to provide strategic, technical, and operational leadership of biostatistics across evidence-generation activities.

This role partners with Medical Affairs leadership and will shape statistically rigorous evidence strategies to support scientific communication, payer needs, and lifecycle planning. The incumbent will lead Phase IV studies, real-world evidence, and observational research; oversee