Manager, Biostatistics
Core
Lead biostatistical activities to support clinical development and post-marketing efforts, ensuring high-quality analytical outputs for regulatory decision-making.
Role type
Manager, Biostatistics
Builds
Statistical deliverables, analysis plans, and evidence generation for clinical trials and real-world data studies.
Domain
Biotechnology / Pharmaceuticals / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design (including adaptive designs), SAS programming, CDISC methodologies, sample size calculations, statistical analysis plan development, regulatory guideline knowledge, cross-functional collaboration, CRO management
Preferred skills
R programming, real-world evidence/observational research methodologies (causal inference), acute or chronic pain indication experience, regulatory interaction support
Technologies
SAS, R, CDISC
Responsibilities
Provide statistical leadership for clinical development programs; manage statistical responsibilities from study design through CSR creation; serve as primary statistical point of contact; contribute to protocol development and study design; review and approve statistical deliverables; manage biostatistics CRO partners; support interactions with regulatory authorities
Seniority
Manager, hands-on IC with team leadership