Senior Biostatistician (Remote) – SAS/R Expert, Regulatory-ready

YO AI Labs; Maryland; Remote; USD 83,000 - 90,000; Full time

Job summary

YO AI Labs in a remote contractor role seeks a Biostatistician to analyze trial data, validate outputs, and ensure regulatory compliance. You will work with SAS and R, review SAPs, CSRs, and TFLs, and collaborate across teams to deliver precise results.

The ideal candidate has 5+ years in biostatistics, with experience in regulatory submissions and data analysis during clinical trials.

Qualifications

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

Responsibilities

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

Skills

SAS

R

CDISC SDTM

ADaM

SAP interpretation

Survival analysis

Mixed models

Covariate adjustment

ICH E9(R1)

TFL QC

Regulatory submissions

CSR review

Documentation

Communication

Analytical skills

Education

MSc or PhD in Biostatistics/Statistics

Tools

SAS software

R software

Job description

YO AI Labs in a remote contractor role seeks a Biostatistician to analyze trial data, validate outputs, and ensure regulatory compliance. You will work with SAS and R, review SAPs, CSRs, and TFLs, and collaborate across teams to deliver precise results.

The ideal candidate has 5+ years in biostatistics, with experience in regulatory submissions and data analysis during clinical trials.