Director, Biostatistics — Rare Disease Clinical Lead

Hemab Therapeutics; Cambridge (MA); A distancia; USD 180.000 - 280.000; Jornada completa

Descripción de la vacante

Hemab Therapeutics is seeking a Director of Biostatistics to lead statistical work for a rare bleeding disorder program in early clinical development. You will shape study design, design endpoints, and analysis plans, guiding decisions with small patient populations and regulatory interactions.

You will collaborate across development teams to embed statistical thinking early and oversee CRO partners to deliver timely, high-quality analyses as the program advances.

Formación

• PhD in Statistics/Biostatistics with 10+ years in pharma/biotech.
• Master's in Statistics/Biostatistics with 15+ years in industry.
• Experience providing statistical input into clinical development strategy, protocol design, endpoint selection and analysis.
• Experience with health authority interactions and NDA/BLA submissions.
• Strong knowledge of adaptive designs, Bayesian methods and simulations.

Responsabilidades

• Lead biostatistical strategy and execution for the clinical development program from design to analysis and interpretation.
• Shape protocols, endpoints and statistical approaches for small patient populations.
• Develop statistical analysis plans and oversee analyses informing decisions.
• Apply adaptive designs, Bayesian methods and simulations where advantageous.
• Contribute statistical input to health authority interactions and regulatory submissions.
• Collaborate with Clinical, Regulatory, Data Management and Medical Affairs to inform development decisions.
• Oversee CRO deliverables and external partners, ensuring quality and timelines.
• Help build practical statistical frameworks as Hemab's pipeline grows.

Conocimientos

Biostatistics leadership

Adaptive designs

Bayesian methods

Regulatory strategy input

Statistical communication

Cross-functional collaboration

Educación

PhD in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Descripción del empleo

Hemab Therapeutics is seeking a Director of Biostatistics to lead statistical work for a rare bleeding disorder program in early clinical development. You will shape study design, design endpoints, and analysis plans, guiding decisions with small patient populations and regulatory interactions.

You will collaborate across development teams to embed statistical thinking early and oversee CRO partners to deliver timely, high-quality analyses as the program advances.