Biostatistician, Clinical Trials & Regulatory Submissions
Overview
You will own statistical analysis for clinical trial data across multiple studies, ensuring regulatory compliance and data integrity. You will collaborate with cross-functional teams to validate outputs and document findings. This role stands out for its focus on statistical quality control and direct support of regulatory submissions.
What You'll Do10
- 1Analyze and validate clinical trial data using SAS and R.
- 2Review and interpret SAPs to ensure alignment with study objectives.
- 3Produce and quality-check TFLs per CDISC standards.
- 4Review CSRs and regulatory submission data for accuracy.
- 5Perform survival analysis, mixed models, and covariate adjustment.
- 6Apply multiplicity control and ICH E9(R1) guidelines.
- 7Collaborate with cross-functional teams to document findings accurately.
- 8Drive the quality control process for statistical outputs.
- 9Support regulatory submissions with sound statistical justifications.
- 10Deliver accurate analysis within tight deadlines.
Requirements9
- 15+ years of Biostatistics experience in clinical trials (Sponsor, CRO, or Academic Research).
- 2MSc or PhD in Biostatistics, Statistics, or a related field.
- 3Hands-on experience with SAS and/or R.
- 4Expertise in CDISC SDTM and ADaM standards.
- 5Strong proficiency in SAP interpretation and survival analysis.
- 6Experience with mixed models, covariate adjustment, and multiplicity control.
- 7Familiarity with ICH E9(R1) guidelines.
- 8Proven track record in TFL production and QC.
- 9Experience with regulatory submissions and CSR review is preferred.
Salary Insight
$125 - $146k per year
Location
Required Skills
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