Senior Director Biostatistics
Core
Lead biostatistical activities across all phases of clinical development for a novel oral medication treating MASH, translating R&D objectives into statistical strategies and regulatory documents.
Role type
Senior Director Biostatistics (Individual Contributor)
Builds
Clinical trial data assets and regulatory submission packages for a Phase 3 outcomes trial
Domain
Biopharmaceuticals / Clinical Development / MASH (Metabolic Dysfunction-Associated Steatohepatitis)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Advanced statistical methods, Clinical trial design, Regulatory submission support (NDA), Statistical Analysis Plan (SAP) development, Cross-functional collaboration, Mentorship
Preferred skills
Experience with CROs, External scientific forum engagement
Technologies
SAS, R, Python
Responsibilities
Represent and lead the statistics function within program teams to drive clinical development strategy; Oversee and coordinate with internal biostatisticians and external CROs; Contribute to clinical/regulatory strategies and submission documents; Perform complex statistical analyses and prepare SAPs; Establish collaborations with cross-functional teams (clinical, data management, pharmacovigilence); Mentor junior R&D members
Seniority
Senior, hands-on IC with strategic oversight
