Apply on Employer Site

Hemab Therapeutics · 2 days ago

Director Biostatistics

Cambridge, MA

Full-time

Onsite

Director/Executive

8+ years exp

Hemab Therapeutics is a clinical-stage biotech company focused on addressing the needs of patients suffering from rare bleeding and thrombotic disorders. As the Director of Biostatistics, you will develop statistical strategies for clinical programs and lead cross-functional collaborations, ensuring scientific rigor and regulatory compliance throughout the development process.

BiotechnologyLife ScienceMedicalPharmaceutical

Responsibilities

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)

Qualification

PhD in Statistics/BiostatisticsClinical development experienceAdaptive trial designsBayesian methodsStatistical Analysis Plans (SAPs)Regulatory submissions experienceProject management skillsMentoring junior statisticiansInfluencing clinical strategyRare diseaseCommunication skills

Required

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

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

Strong project management skills handling multiple concurrent programs