Biostatistician, Clinical Trials & Regulatory Submissions
Overview
You will own statistical analysis and validation for clinical trial data across multiple studies, directly supporting regulatory submissions. Your work ensures compliance and accuracy in all outputs. You will join a remote team of biostatisticians and data professionals, collaborating with cross-functional teams. This contract role offers $60–$65 per hour and the chance to impact drug development.
What You'll Do8
- 1Analyze and validate clinical trial data using SAS and/or R.
- 2Review and interpret Statistical Analysis Plans (SAPs) to ensure alignment with study objectives.
- 3Produce and quality-check Tables, Figures & Listings (TFLs) for accuracy and completeness.
- 4Review Clinical Study Reports (CSRs) and regulatory submission data for compliance.
- 5Apply survival analysis, mixed models, and covariate adjustment to answer study questions.
- 6Implement multiplicity control methods per ICH E9(R1) guidelines.
- 7Document statistical findings and decisions clearly for internal and regulatory audiences.
- 8Collaborate with cross-functional teams to resolve data issues and ensure timely deliverables.
Requirements9
- 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 clinical trial analysis.
- 4Working knowledge of CDISC standards: SDTM and ADaM.
- 5Hands-on experience with SAP interpretation and TFL production.
- 6Experience with survival analysis, mixed models, and covariate adjustment.
- 7Understanding of multiplicity control and ICH E9(R1) guidelines.
- 8Familiarity with regulatory submissions and CSR review.
- 9Strong documentation, communication, and analytical skills.
Salary Insight
$125 - $146k per year
Location
Required Skills
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