Principal Biostatistician, PKPD
Warman O'Brien
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 View email address on click.appcast.io 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 #J-18808-Ljbffr Warman O'Brien
Vacancy posted 5 days ago
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