Remote Biostatistician Expert – SAS/R & Regulatory Submissions

YO AI Labs; Los Angeles (CA); Remote; USD 83,000 - 90,000; Part time

Job summary

YO AI Labs is seeking an experienced Biostatistician to support clinical research by analyzing trial data, validating outputs, and ensuring regulatory compliance. The role emphasizes SAS and/or R analyses, TFL production, and CSR reviews in a remote contractor setting.

Qualified candidates have 5+ years in biostatistics, an advanced degree, and experience with SDTM/ADaM, ICH E9(R1), and regulatory submissions. Strong documentation and cross-functional collaboration are essential.

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.

Responsibilities

• Analyze and validate clinical trial data.
• Review and interpret SAPs.
• Produce and quality-check TFLs.
• Review CSRs and regulatory submission data.
• Perform statistical analyses using SAS and/or R.
• Collaborate with cross-functional teams and document findings accurately.

Skills

SAS

R

CDISC SDTM/ADaM

SAP interpretation

Survival analysis

Mixed models

Covariate adjustment

Multiplicity control

ICH E9(R1)

Clinical trial data analysis

TFL production

Regulatory submissions

CSR review

Documentation & communication

Education

MSc or PhD in Biostatistics, Statistics, or a related field

Job description

YO AI Labs is seeking an experienced Biostatistician to support clinical research by analyzing trial data, validating outputs, and ensuring regulatory compliance. The role emphasizes SAS and/or R analyses, TFL production, and CSR reviews in a remote contractor setting.

Qualified candidates have 5+ years in biostatistics, an advanced degree, and experience with SDTM/ADaM, ICH E9(R1), and regulatory submissions. Strong documentation and cross-functional collaboration are essential.