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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.
Job Responsibility:
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
Mentor/manage junior statistician(s)
Requirements:
PhD in Statistics/Biostatistics with 8+ years for Director pharmaceutical/biotech industry experience
Master's degree in Statistics/Biostatistics with 12+ years pharmaceutical/biotech industry experience
Extensive clinical development experience from early to late stage is required
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
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