Biostatistician Expert - Remote

About the role

We are looking for an experienced Biostatistician to support clinical research projects by analyzing clinical trial data, validating statistical outputs, and ensuring compliance with regulatory standards.

Responsibilities

• Analyze and validate clinical trial data.
• Review and interpret Statistical Analysis Plans (SAPs).
• Produce and quality-check Tables, Figures & Listings (TFLs).
• Review Clinical Study Reports (CSRs) and regulatory submission data.
• Perform statistical analyses using SAS and/or R.
• Collaborate with cross-functional teams and document findings accurately.

Requirements

• 5+ years of Biostatistics experience in clinical trials (Sponsor, CRO, or Academic Research).
• MSc or PhD in Biostatistics, Statistics, or a related field.
• Experience with regulatory submissions and statistical quality control is preferred.

Skills

• SAS and/or R
• CDISC SDTM & ADaM
• SAP interpretation
• Survival analysis, mixed models, covariate adjustment
• Multiplicity control & ICH E9(R1)
• Clinical trial data analysis
• TFL production & QC
• Regulatory submissions & CSR review
• Strong documentation, communication, and analytical skills

Pay

$60–$65/hour