Principal Biostatistician, PKPD

Warman O'Brien; United States; Remote; USD 100,000 - 130,000; Full time

Job summary

A leading global CRO is seeking a Principal Biostatistician to provide scientific and statistical leadership in early-phase studies focused on PK/PD. Responsibilities include leading study design, conducting analyses, and mentoring team members. Required qualifications include a PhD with industry experience or an MS with extensive experience. The role is fully remote and offers the chance to impact groundbreaking therapies.

Qualifications

• PhD + 3 years or MS + 5 years industry experience.
• 2+ years hands-on non-compartmental PK analysis.
• Strong understanding of early-phase statistical principles.

Responsibilities

• Lead statistical design and planning for early-phase clinical studies.
• Provide input to protocols, synopses, and SAPs.
• Conduct and validate statistical analyses.

Skills

Statistical design and planning

Statistical analyses (SAS/R)

Communication skills

Leadership skills

Non-compartmental PK analysis

Understanding of statistical principles

Education

PhD in a relevant field

MS in a relevant field

Tools

SAS

R

CDISC (SDTM/ADaM/CDASH)

Job description

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 [e-mail] 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