Principal Statistician
Core
Design clinical studies, guide statistical strategy, and ensure statistical deliverables meet scientific and regulatory standards for late-stage drug development.
Role type
Principal Statistician (Pharmaceuticals)
Builds
Pivotal clinical trials and regulatory submissions for late-stage drug development programs
Domain
Healthcare / Pharmaceutical Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
statistical inference, experimental design, clinical trial methodology, ICH guidelines, CDISC requirements, advanced modeling techniques, SAS, R
Preferred skills
MSc or PhD in Statistics/Biostatistics, experience overseeing CRO statisticians, track record of FDA/EMA drug approvals
Technologies
SAS, R
Responsibilities
Provide statistical leadership for Phase 2/3 and late-stage development; Serve as primary statistical authority for pivotal trials; Take accountability for statistical deliverables including Clinical Development Plans; Respond to health authority queries and represent company with regulatory agencies; Partner with clinical teams to drive evidence-based decisions; Lead statistical oversight for outsourced studies; Contribute to publications and internal best practices
Seniority
Principal, strategic advisor and hands-on technical lead
