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.
What You’ll Do
- 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.
What You’ll Bring
- 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.
Bonus
- Modeling/simulation, PD, or biomarker analysis experience.
Ready to make an impact at the ground floor of drug development?
Contact or click apply today.
Job Details
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Other and Analyst
Industries: Pharmaceutical Manufacturing, Biotechnology Research, and Research Services
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