Hemab Therapeutics
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Director Biostatistics
role at
Hemab Therapeutics . Hemab is a clinical‑stage biotech company focused on rare bleeding and thrombotic disorders, with offices in Cambridge, MA and Copenhagen, Denmark.
As
Director, Biostatistics , you will develop the statistical strategy for our leading rare bleeding disorder program in early clinical development. You will serve as the senior statistical leader, partnering closely with clinical, regulatory, and executive teams to optimize trial designs for small patient populations while maintaining scientific rigor and regulatory compliance.
What you’ll Do at Hemab
Lead statistical input for clinical development plans, protocol design, endpoint selection, data analysis and interpretation.
Develop innovative trial designs including adaptive and Bayesian approaches to maximize learning from limited patient populations.
Author and review Statistical Analysis Plans (SAPs) and statistical sections of regulatory documents, and perform statistical analyses to inform decision‑making.
Develop quantitative decision frameworks for dose‑finding and proof‑of‑concept studies.
Provide strategic statistical guidance for go/no‑go decisions and portfolio prioritization.
Prepare statistical components for regulatory submissions (INDs, NDAs/BLAs, CSRs).
Oversee CRO statistical deliverables and vendor relationships.
Lead cross‑functional collaboration with Clinical Research, Clinical Pharmacology, Clinical Operations, Data Management, Regulatory Affairs, and Medical Affairs.
Foster innovation in statistical methodology and process improvement.
Who You Are and What You’ll Bring to Hemab
PhD in Statistics/Biostatistics with 8+ years of industry experience, or Master’s with 12+ years.
Extensive clinical development experience from early to late stage; NDA/BLA submission experience strongly preferred.
Demonstrated ability to influence clinical development strategy and executive decision‑making.
Excellent communication skills, able to present complex statistical concepts to non‑statistical audiences.
Experience with adaptive trial designs, Bayesian methods, and simulation techniques.
Direct experience with rare disease or hematology clinical trials highly desirable.
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Director Biostatistics
role at
Hemab Therapeutics . Hemab is a clinical‑stage biotech company focused on rare bleeding and thrombotic disorders, with offices in Cambridge, MA and Copenhagen, Denmark.
As
Director, Biostatistics , you will develop the statistical strategy for our leading rare bleeding disorder program in early clinical development. You will serve as the senior statistical leader, partnering closely with clinical, regulatory, and executive teams to optimize trial designs for small patient populations while maintaining scientific rigor and regulatory compliance.
What you’ll Do at Hemab
Lead statistical input for clinical development plans, protocol design, endpoint selection, data analysis and interpretation.
Develop innovative trial designs including adaptive and Bayesian approaches to maximize learning from limited patient populations.
Author and review Statistical Analysis Plans (SAPs) and statistical sections of regulatory documents, and perform statistical analyses to inform decision‑making.
Develop quantitative decision frameworks for dose‑finding and proof‑of‑concept studies.
Provide strategic statistical guidance for go/no‑go decisions and portfolio prioritization.
Prepare statistical components for regulatory submissions (INDs, NDAs/BLAs, CSRs).
Oversee CRO statistical deliverables and vendor relationships.
Lead cross‑functional collaboration with Clinical Research, Clinical Pharmacology, Clinical Operations, Data Management, Regulatory Affairs, and Medical Affairs.
Foster innovation in statistical methodology and process improvement.
Who You Are and What You’ll Bring to Hemab
PhD in Statistics/Biostatistics with 8+ years of industry experience, or Master’s with 12+ years.
Extensive clinical development experience from early to late stage; NDA/BLA submission experience strongly preferred.
Demonstrated ability to influence clinical development strategy and executive decision‑making.
Excellent communication skills, able to present complex statistical concepts to non‑statistical audiences.
Experience with adaptive trial designs, Bayesian methods, and simulation techniques.
Direct experience with rare disease or hematology clinical trials highly desirable.
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