Director, Biostatistics

Join Hemab , a clinical-stage biotech company, on an exciting journey to build the ultimate clotting company. We focus on addressing the high unmet needs of patients suffering from rare bleeding and thrombotic disorders. With offices in Cambridge, MA, USA, and Copenhagen, Denmark, Hemab cultivates a vibrant, agile, and forward-thinking environment where collaboration, innovation, and high-quality biotherapeutics development go hand in hand.

As Director, Biostatistics , you will be responsible for developing statistical strategy for our leading rare bleeding disorder program currently in early clinical development. This pivotal role combines deep statistical expertise with strategic leadership to guide our innovative 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 .

At Hemab, we foster an environment where everyone can wear ‘multiple hats’ depending on their experience and motivation to get things done ‘right first time’. We constantly strive to celebrate our achievements collectively and gather feedback to sustain and improve our fast-paced cross-functional work environment continuously.

• Lead statistical input for clinical development plans, protocol design, endpoint selection, data analysis and interpretation.
• Develop innovative trial designs including but not limited to 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.

• PhD in Statistics/Biostatistics with 8+ years for Director pharmaceutical/biotech industry experience, OR Master's degree in Statistics/Biostatistics with 12+ years pharmaceutical/biotech industry experience
• Extensive clinical development experience from early to late stage is required, and 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