Job Description
Senior Biostatistician | US Remote
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We’re supporting a life sciences organisation looking for an experienced Biostatistician to join their clinical development team.
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The role will sit at the intersection of statistics, clinical data and programming, with a strong focus on reviewing data and outputs from external partners and ensuring they meet the required standards before being used for analysis.
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The role
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- Review clinical data and external data transfers for quality, completeness and consistency
- Review SDTM and ADaM datasets, specifications and programming outputs, checking that they align with CDISC standards and study requirements
- Provide input into SAPs, TLFs, protocols and other key study documentation
- Follow data through the process from source data to SDTM and ADaM, identifying potential issues or inconsistencies
- Review and validate statistical outputs, with a focus on accuracy, traceability and reproducibility
- Work closely with internal study teams and external vendors to resolve data and analysis issues
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What we’re looking for
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- Solid experience in Biostatistics within clinical development
- Strong understanding of clinical trial data and CDISC standards, particularly SDTM and ADaM
- Some hands-on SAS and/or R programming experience, sufficient to review programming logic, datasets and outputs against specifications and standards
- Strong statistical knowledge and understanding of study design
- Highly detail-oriented, analytical and comfortable challenging data or outputs where required
- Strong communication skills and experience working with cross-functional teams and external partners
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Education/Experience : PhD with 3+ years' relevant experience, or Master's degree with 6+ years' relevant experience.