Principal Biostatistician, PKPD

Principal Biostatistician – Early Phase (PK/PD)

Remote (U.S. or Canada) | FSP Model

Looking to shape the earliest stages of drug development? We’re partnering with a leading global CRO to hire a Principal Biostatistician to provide scientific and statistical leadership across early-phase studies focused on PK/PD. Your insights will influence strategy, IND decisions, and the future of breakthrough therapies.

• Lead statistical design and planning for early-phase clinical studies.
• Provide input to protocols, synopses, and SAPs.
• Review and guide programming deliverables (datasets, TLFs).
• Conduct and validate statistical analyses (SAS/R).
• Interpret results for clinical, pharmacology, and regulatory teams.
• Support exploratory analyses to inform next-phase strategy.
• Mentor programmers and contribute to cross-functional planning.

• PhD + 3 yrs (or MS + 5 yrs) industry experience.
• 2+ yrs hands‑on non‑compartmental PK analysis.
• Strong understanding of early‑phase statistical principles.
• Experience with CDISC (SDTM/ADaM/CDASH).
• Proficiency in SAS; R a plus.
• Excellent communication and leadership skills.

• Modeling/simulation, PD, or biomarker analysis experience.

Ready to make an impact at the ground floor of drug development?

Contact or click apply today.

Seniority level:
Mid‑Senior level

Employment type:

Full‑time

Job function:
Other and Analyst

Industries:
Pharmaceutical Manufacturing, Biotechnology Research, and Research Services