Principal Biostatistician – Early Phase Clinical Development (PK)
Location: Remote (U.S. or Canada)
Company: IQVIA – Data Sciences Staffing Solutions (DSSS)
Job Type: Full-Time
Job Summary:
IQVIA’s DSSS unit is seeking a Principal Biostatistician to support early phase drug development studies, especially pharmacokinetics (PK) and pharmacodynamics (PD) trials in healthy populations. This home-based opportunity is ideal for experienced clinical statisticians with strong SAS programming, CDISC familiarity, and a background in early-phase clinical development. Join a global CRO delivering impactful data solutions across world-class pharmaceutical and biotech sponsors.
Key Responsibilities:
Provide statistical guidance on protocols and study designs with a PK/PD focus
Contribute to sample size calculations and randomization plans
Write and review Statistical Analysis Plans (SAPs), TLF specs, and analysis datasets
Collaborate with cross-functional teams including Data Management and Clinical Pharmacology
Perform and validate inferential analyses using SAS or R
Interpret and summarize study results in clinical reports and regulatory documents
Guide and review statistical programming deliverables
Support exploratory analyses and contribute to IND documentation
Maintain timelines and deliverables across internal and CRO stakeholders
Required Skills & Qualifications:
PhD in Statistics/Biostatistics with 3+ years industry experience OR
MS with 5+ years industry experience
2+ years analyzing non-compartmental PK endpoints
Proficiency in SAS (and/or R) for data derivation and validation
Experience with CDISC standards (SDTM, ADaM, CDASH)
Knowledge of ICH GCP and clinical pharmacology regulatory guidance
Ability to lead projects independently and manage programming teams
Strong communication and decision-making skills
Desired Experience:
Familiarity with statistical modeling, PD/biomarker analysis, simulations
Experience in early phase, healthy volunteer trials
Perks & Benefits:
Salary Range: $115,900 – $243,900 annually (depending on experience and location)
100% Remote work across U.S. or Canada
Flexible scheduling and strong work-life balance
Long-term FSP assignments with re-deployment opportunities
Exposure to novel study designs and breakthrough therapies
Technical training and custom career development support
Collaborative, global team culture in a fast-paced setting
About IQVIA:
IQVIA is a global leader in clinical research, healthcare data analytics, and real-world evidence solutions. Through DSSS (Data Sciences Staffing Solutions), IQVIA offers embedded opportunities with top-tier pharmaceutical clients, helping to shape the future of medicine.
Work Mode: Remote (Home-based in U.S. or Canada)
Apply Now
Ready to lead early phase clinical research with one of the world’s top CROs? Apply now and become a key contributor to innovative drug development at IQVIA.
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