Posted over 30 days ago. Roles like this often stay open for a while, so it's still worth applying.
Biostatistician at micro1
posted 3 months agoBiostatistician | $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.