Biostatistician Expert Remote

Location: Remote
Job Type: Contractor
Pay: $60$65/hour

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.

• 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.

• 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

• 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.