Remote Principal Biostatistician for Clinical Trials

IQVIA LLC; Northern (KY); Hybrid; USD 96,000 - 309,000; Full time

Benefits offered by this job

Remote work

Flexible schedules

Training & development

Career growth

Job summary

IQVIA LLC – Data Sciences Staffing Solutions (DSSS) is seeking a Principal Biostatistician to provide statistical support for pharmaceutical clinical trials and to lead study design efforts including sample size and power calculations.

The role offers home-based remote work in the U.S. and Canada with opportunities for collaboration across sponsor teams and regulatory submissions. Strong expertise in R/SAS, CDISC, and estimands is required.

Qualifications

• PhD or MS with industry experience in pharmaceutical clinical trials.
• Experience with regulatory submissions and FDA guidance.
• Strong ability to communicate statistical ideas to cross-functional teams.

Responsibilities

• Collaborate with multi-disciplinary project teams to establish objectives and timelines.
• Perform sample size and power calculations for study design optimization.
• Author statistical analysis plans.
• Review analysis datasets and TLF specifications.
• Provide guidance to programmers on dataset specifications and validation.
• Interpret study results and prepare reports for regulatory documents.

Skills

Sample size calculations

R programming

SAS programming

Regulatory submissions

CDISC SDTM/ADaM/CDASH

Estimands & multiple imputation

Cross functional collaboration

Education

PhD in Statistics/Biostatistics

MS in Statistics/Biostatistics

Tools

R

SAS

ADAM/TLF validation

CDISC tooling

Job description

IQVIA LLC – Data Sciences Staffing Solutions (DSSS) is seeking a Principal Biostatistician to provide statistical support for pharmaceutical clinical trials and to lead study design efforts including sample size and power calculations.

The role offers home-based remote work in the U.S. and Canada with opportunities for collaboration across sponsor teams and regulatory submissions. Strong expertise in R/SAS, CDISC, and estimands is required.