Biostatistician

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.