Biostatistician, Clinical Trials & SAS
Overview
Biostatistician owns statistical analysis for clinical trial data, ensuring regulatory compliance and data integrity. You join a cross-functional team supporting sponsors and CROs remotely. This role stands out by offering direct involvement in regulatory submissions and quality control, with clear expectations for 5+ years of experience and expertise in SAS or R.
What You'll Do8
- 1Analyze and validate clinical trial data with SAS or R
- 2Review and interpret Statistical Analysis Plans (SAPs) for adherence to study protocols
- 3Produce and quality-check Tables, Figures & Listings (TFLs) to support regulatory submissions
- 4Review Clinical Study Reports (CSRs) and ensure statistical outputs meet regulatory standards
- 5Apply survival analysis, mixed models, and covariate adjustment methods in statistical models
- 6Control multiplicity per ICH E9(R1) guidelines in all analyses
- 7Collaborate with cross-functional teams to document findings accurately
- 8Support regulatory submissions by delivering validated statistical outputs
Requirements8
- 15+ years of Biostatistics experience in clinical trials
- 2MSc or PhD in Biostatistics, Statistics, or a related field
- 3Proficiency in SAS and/or R for statistical analysis
- 4Knowledge of CDISC SDTM & ADaM standards
- 5Experience interpreting SAPs and producing TFLs
- 6Applied survival analysis, mixed models, and covariate adjustment
- 7Expertise in multiplicity control per ICH E9(R1)
- 8Track record in regulatory submissions and statistical quality control
Salary Insight
$125 - $146k per year
Location
Required Skills
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