Principal Biostatistician – Early Phase Clinical Development (PK)
PB-EPCD(PK)_ 4319575318
Posted: 29/10/2025
- United States (Remote)
- Contract
Principal / Senior Biostatistician – Early Phase Clinical Development (PK)
About the Role
We’re seeking a Principal or Senior Biostatistician to support early-phase clinical programs, focusing on healthy volunteer studies with PK/PD endpoints. You’ll play a key role in statistical strategy, analysis, and cross-functional collaboration within innovative study teams.
What You’ll Do
- Provide statistical input for protocols, study synopses, and analysis plans
- Conduct and validate inferential analyses using SAS and/or R
- Oversee programming deliverables (datasets, tables, listings, figures)
- Partner with Data Management, Clinical Development, and Clinical Pharmacology teams
- Contribute to study reports and regulatory documents
What You Bring
- PhD in Statistics/Biostatistics with 3+ years, or MS with 5+ years industry experience
- 2+ years of experience analyzing non-compartmental PK endpoints
- Proficiency in SAS; experience with R a plus
- Solid understanding of ICH GCP and CDISC standards (SDTM, ADaM, CDASH)
- Strong communication and leadership in cross-functional settings#
Why You’ll Love Working Here
✅ 100% remote flexibility
✅ Meaningful, long-term projects (not just budgets & change orders)
✅ Growth-focused culture and technical development programs
✅ Work-life balance within a high-performing team
Ready to shape the future of early drug development? Apply now!
Slavena Ivanova
Senior Candidate Consultant
