warman obrienNew York, NY
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.
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 Brook@warmanobrien.com 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
Also on the board Same function, level within a rung
Level
Lead
Location
New York, NY
Occupation
Biostatisticians
Industry
Research and Development in Biotechnology
Posted
today