Biostatistician, Clinical Trials & SAS
Overview
You will own statistical analysis and validation for clinical trial data, shaping studies from SAP to regulatory submission. You join a remote-friendly team supporting sponsors and CROs, using SAS and R to produce TFLs and review CSRs. Your work directly impacts drug development and regulatory approval, offering deep experience across therapeutic areas.
What You'll Do7
- 1Analyze and validate clinical trial data using SAS or R, ensuring accuracy and completeness.
- 2Review and interpret Statistical Analysis Plans to guide study execution.
- 3Produce and quality-check Tables, Figures & Listings per CDISC standards.
- 4Review Clinical Study Reports and regulatory submission data for compliance.
- 5Perform statistical analyses including survival analysis, mixed models, and covariate adjustment.
- 6Apply multiplicity control and ICH E9(R1) principles to study design.
- 7Collaborate with cross-functional teams to document findings.
Requirements7
- 15+ years of Biostatistics experience in clinical trials (Sponsor, CRO, or Academic Research).
- 2MSc or PhD in Biostatistics, Statistics, or related field.
- 3Proficiency in SAS and/or R for clinical data analysis.
- 4Working knowledge of CDISC SDTM and ADaM standards.
- 5Experience with SAP interpretation and TFL production.
- 6Experience with regulatory submissions and CSR review.
- 7Strong documentation, communication, and analytical skills.
Salary Insight
$125 - $146k per year
Location
Required Skills
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