Biostatistician, Clinical Trials & SAS
Overview
Own the statistical integrity of clinical trial data at YO AI Labs, a remote-first research organization. You will analyze and validate datasets, drive the delivery of Tables, Figures & Listings (TFLs), and ensure full compliance with regulatory standards like ICH E9(R1). Joining a lean team of biostatisticians and data scientists, you will collaborate directly with clinical and regulatory experts. This contract role offers the chance to shape submission-ready outputs across multiple therapeutic areas, with a focus on quality and precision.
What You'll Do7
- 1Analyze and validate clinical trial data using SAS or R, ensuring accuracy and completeness across all datasets.
- 2Review and interpret Statistical Analysis Plans (SAPs) to align statistical methods with study objectives and regulatory expectations.
- 3Produce and quality-check Tables, Figures & Listings (TFLs) for clinical study reports and regulatory submissions.
- 4Review Clinical Study Reports (CSRs) and regulatory submission data, resolving discrepancies and documenting decisions.
- 5Apply survival analysis, mixed models, and covariate adjustment techniques to address complex trial endpoints.
- 6Implement multiplicity control methods per ICH E9(R1) guidelines to protect overall Type I error rates.
- 7Collaborate with cross-functional teams including data management, clinical operations, and medical writing, documenting findings accurately.
Requirements8
- 15+ years of Biostatistics experience in clinical trials (Sponsor, CRO, or Academic Research).
- 2MSc or PhD in Biostatistics, Statistics, or a related field.
- 3Proficiency in SAS and/or R for statistical analysis and data manipulation.
- 4Experience with CDISC standards including SDTM and ADaM for clinical trial data structures.
- 5Strong understanding of SAP interpretation and TFL production and QC.
- 6Experience with survival analysis, mixed models, and covariate adjustment.
- 7Working knowledge of multiplicity control and ICH E9(R1) guidelines.
- 8Experience with regulatory submissions and statistical quality control is preferred.
Salary Insight
$125 - $146k per year
Location
Required Skills
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