Senior Biostatistician

Senior Biostatistician | US Remote

We’re supporting a life sciences organisation looking for an experienced Biostatistician to join their clinical development team.

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.

The role

• 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

What we’re looking for

• 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

Education/Experience : PhD with 3+ years' relevant experience, or Master's degree with 6+ years' relevant experience.