Remote Director, Biostatistics – Early-Stage

Hemab Therapeutics; United States; Remote; USD 180,000 - 250,000; Full time

Job summary

Hemab Therapeutics in Cambridge, MA (remote east coast allowed) seeks a Director, Biostatistics to lead biostatistical work for a rare bleeding disorder program in early clinical development. You will shape study design, analysis plans and interpretation, helping the team make sound decisions from small patient populations.

You will oversee statistical strategy, collaborate across Clinical Research, Regulatory and Medical Affairs, and manage CRO partners to ensure quality, timeliness and

Qualifications

• PhD in Statistics/Biostatistics with 10+ years of pharmaceutical or biotech industry experience.
• OR a Master's in Statistics/Biostatistics with 15+ years of relevant industry experience.
• Clinical development biostatistics experience across multiple stages of development.
• Experience providing statistical input into clinical development strategy, protocol design, endpoint selection and analysis.
• Experience contributing directly to health authority interactions and regulatory discussions - including NDA/BLA submission experience.
• Strong working knowledge of statistical methods used in clinical development, including adaptive designs, Bayesian methods and simulation techniques.
• The ability to explain complex statistical questions clearly and influence decisions with clinical, regulatory and other non-statistical colleagues.

Responsibilities

• Lead biostatistical strategy and execution for an assigned clinical development program, from study design through analysis and interpretation.
• Shape protocols, endpoints and statistical approaches that answer the right clinical questions while making effective use of small patient populations.
• Develop statistical analysis plans and oversee the statistical analyses that inform program and study decisions.
• Apply adaptive designs, Bayesian methods and simulation where they offer a clear scientific or development advantage.
• Contribute statistical expertise to health authority interactions, regulatory documents and submissions, partnering with the VP, Head of Biometrics on regulatory strategy.
• Work closely with Clinical Research, Clinical Pharmacology, Clinical Operations, Data Management, Regulatory Affairs and Medical Affairs to bring statistical thinking into development decisions early.
• Oversee CRO statistical deliverables and external partners, taking ownership of quality, timelines and resolution of issues.
• Help build practical statistical frameworks and ways of working as Hemab's pipeline and Biometrics function grow.

Skills

PhD in Biostatistics

Clinical development experience

NDA/BLA experience

Bayesian methods

Adaptive designs

Communication skills

Education

PhD in Statistics/Biostatistics

Master's in Statistics/Biostatistics

Tools

SAS

R

Job description

Hemab Therapeutics in Cambridge, MA (remote east coast allowed) seeks a Director, Biostatistics to lead biostatistical work for a rare bleeding disorder program in early clinical development. You will shape study design, analysis plans and interpretation, helping the team make sound decisions from small patient populations.

You will oversee statistical strategy, collaborate across Clinical Research, Regulatory and Medical Affairs, and manage CRO partners to ensure quality, timeliness and