Biostatistician Expert - Remote

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.

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

Qualifications

• 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.

Pay

$60–$65/hour