Director, Biostatistics

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

Location

Cambridge, MA, USA (or remote east coast, USA)

Reporting to

VP, Head of Biometrics

About Hemab

Hemab is building preventative treatments for serious, underserved bleeding disorders. These are therapies designed to work with the body's own biology and stop bleeds before they start, instead of treating them after they happen. We're patient-first, science-led and clinical-stage - with a pipeline that takes different scientific approaches to different patient needs.

We went public via our 2026 IPO, and we're scaling across two homes: Cambridge, MA, USA, and Copenhagen, Denmark.

The role

As Director, Biostatistics, you'll lead biostatistical work for a rare bleeding disorder program in early clinical development. Working closely with the VP, Head of Biometrics and colleagues across development, you'll shape study design, analysis and interpretation, helping Hemab make sound decisions from limited patient populations and build the evidence needed as the program advances.

What you'll do

• 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.

What you'll bring to Hemab

• PhD in Statistics/Biostatistics with 10+ years of pharmaceutical or biotech industry experience
• OR a Master's degree 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.

Nice to have

• Rare disease, hematology or bleeding disorder clinical development experience.
• Experience helping build statistical capabilities or ways of working in a growing biotech company.
• Experience providing statistical guidance or mentoring to less experienced colleagues.

What to expect, honestly

Hemab is still building a lot of its own structure. Systems here tend to get created as we need them, not handed down in advance. Whoever takes this role will likely build some of their own process instead of inheriting a finished one. We work across two hubs and multiple time zones - bridging that well takes real, deliberate effort.

This is the actual shape of working somewhere at this stage: It's genuinely energising for the right person and genuinely frustrating for the wrong one. If you want a place where the operating manual is already written, this might not be it - but if you want to help write it, this might be exactly it.

Why Hemab

Your statistical decisions will ultimately connect back to patients living with serious bleeding disorders and our goal of giving them the chance to prevent a bleed instead of reacting to one after it happens. You'll join while individual scientific and development decisions still carry real weight, with the opportunity to help turn promising science into preventative treatments for patients.

How we treat our people is meant to be an extension of how we think about patients: with care, honesty, and respect. We're still building the consistency to back that up across every hiring process, every time. We'd say that plainly instead of pretending otherwise. If any part of your experience with us falls short of it, tell us.

Hemab builds balanced candidate slates and assesses everyone against a single standard. If you need a reasonable adjustment at any stage of the hiring process, please tell us.

Hemab Therapeutics is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, creed, gender, national origin, age, disability, veteran status, pregnancy, sex, marital status, gender expression or identity, genetic information, sexual orientation, citizenship, or any other legally protected class.