Senior Biostatistician

Consult; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

Consult is seeking an experienced Biostatistician to join our clinical development team. The role sits at the intersection of statistics, clinical data and programming, focusing on reviewing data from external partners and ensuring readiness for analysis.

You will review SDTM and ADaM datasets and outputs, contribute to SAPs, TLFs and study protocols, and work with cross‑functional teams to resolve data issues while maintaining traceability and reproducibility.

Qualifications

• PhD with 3+ years or a Master’s with 6+ years in biostatistics or related field
• Strong experience with CDISC SDTM/ADaM and clinical trial data
• Experience reviewing external data transfers and programming outputs
• Proficiency with SAS and/or R for reviewing analyses and outputs
• Attention to data quality, traceability and reproducibility
• Excellent cross‑functional communication skills and collaboration with vendors

Responsibilities

• Review clinical data and external data transfers for quality, completeness and consistency
• Review SDTM and ADaM datasets, specifications and programming outputs
• Provide input into SAPs, TLFs, protocols and other key study documentation
• Follow data through the process from source data to SDTM and ADaM, identifying issues
• Review and validate statistical outputs with focus on accuracy and reproducibility
• Work with internal study teams and external vendors to resolve data and analysis issues

Skills

Biostatistics

Clinical development

Data quality review

Education

PhD or MSc in a related field

Biostatistics emphasis

Tools

SAS

R

Job description

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.