Biostatistician at micro1

Biostatistician | $60–65/hr | Worldwide Remote

We are seeking an experienced Biostatistician to support clinical trial data analysis and regulatory submission activities. This is a specialist contractor role within the medical domain, ideal for a detail-oriented professional with deep expertise in statistical methodologies and clinical data standards.

Key Responsibilities

• Interpret and implement Statistical Analysis Plans (SAPs) for clinical trials
• Perform advanced statistical analyses including survival analysis, mixed models, covariate adjustment, and multiplicity control
• Apply estimand and missing-data strategies in accordance with ICH E9(R1) guidelines
• Produce and quality-control Tables, Figures, and Listings (TFLs) for regulatory submissions
• Support the preparation of regulatory submission packages and review Clinical Study Reports (CSRs)
• Ensure compliance with CDISC SDTM and CDISC ADaM data standards
• Maintain thorough documentation and contribute to statistical quality control processes
• Collaborate cross-functionally with clinical, medical, and regulatory teams

Required Skills

• Proficiency in SAS and R for statistical programming
• Strong knowledge of CDISC SDTM and CDISC ADaM standards
• Experience with survival analysis, mixed models, and multiplicity control
• Familiarity with ICH E9(R1) estimand framework and missing-data strategies
• Proven ability to produce and QC TFLs for regulatory submissions
• Excellent written communication, critical thinking, and attention to detail

This role offers the opportunity to contribute meaningfully to clinical research and regulatory science in a fully remote, collaborative environment.