Lead PK/PD Biostatistician – Early-Phase Trials

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

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.