Director Biostatistics at Hemab

Director Biostatistics at Hemab

Hemab Therapeutics is a clinical‑stage biotech company focused on addressing high unmet needs of patients suffering from rare bleeding and thrombotic disorders. With offices in Cambridge, MA and Copenhagen, Denmark, we cultivate a vibrant, agile, and forward‑thinking environment that emphasizes collaboration, innovation, and high‑quality biotherapeutics development.

As Director, Biostatistics
, you will develop statistical strategy for our leading rare bleeding disorder program in early clinical development. This pivotal role combines deep statistical expertise with strategic leadership to guide our therapy from proof‑of‑concept through regulatory approval. You will serve as the senior statistical leader for the program, partnering closely with clinical, regulatory, and executive teams to optimize trial designs for small patient populations while maintaining scientific rigor and regulatory compliance.

• 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.

• Ph.D. in Statistics/Biostatistics with 8+ years of director‑level pharmaceutical/biotech industry experience, OR Master’s degree with 12+ years of industry experience.
• 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 with ability 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.

Mid‑Senior level

Full‑time

Science and Research