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 the Associate Director/Director, Biostatistics, you will be responsible for lead statistical strategy for our 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 statistical lead for our entire development program, partnering closely with clinical, regulatory, and executive teams to optimize trial designs for small patient populations while maintaining scientific rigor.
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.
What you’ll Do at Hemab
- Lead statistical input for protocol design, endpoint selection, and sample size optimization for rare bleeding disorder trials
- 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), table/listing/figure specifications, and statistical sections of regulatory documents, and perform statistical analyses
- 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 5+ years for Associate Director and 8+ years for Director pharmaceutical/biotech industry experience, OR
- Master's degree in Statistics/Biostatistics with 7+ years for Associate Director and 10+ years pharmaceutical/biotech industry experience
- Clinical development experience from early to late stage is required, and NDA/BLA submission experience strongly preferred
- Experience with adaptive trial designs, Bayesian methods, and simulation techniques
- Advanced proficiency in SAS programming and R is required
- Direct experience with rare disease or hematology clinical trials highly desirable
- Excellent communication skills with ability to present complex statistical concepts to non-statistical audiences
- Strategic thinking with track record of influencing clinical development decisions
- Strong project management skills handling multiple concurrent programs
