Embedded Biostatistics Associate Director – Clinical Trials

Cytel; Helena (MT); On-site; USD 140,000 - 200,000; Full time

Job summary

Cytel is seeking an Associate Director of Biostatistics to support or lead clinical trials for drug development within an FSP framework. You will contribute to study concepts, SAPs, protocols, and regulatory documents, while providing expert biostatistical input and oversight of external resources.

The role emphasizes advanced statistical methods, machine learning and collaboration across departments to drive efficiency and innovation in statistical analysis.

Qualifications

• Master’s degree in Statistics with 7+ years in biotech/pharma.
• PhD preferred; strong statistical methods background.
• Proficient in R, SAS, Python; regulatory submissions knowledge.
• Experience with CDISC, SDTM and ADaM standards.

Responsibilities

• Support statistical strategy for drug programs and study SAPs.
• Oversee biostatistics deliverables produced by external resources.
• Contribute to protocols, CSRs, and scientific presentations.
• Review randomization procedures and randomization lists.
• Review CRFs and data management plans for statistical needs.
• Oversee outsourced CRO activities for timely quality.
• Develop innovative statistical tools and cross-functional initiatives.

Skills

Statistical analysis

R

SAS

Python

Regulatory knowledge

Vendor management

Machine learning

Communication skills

Education

Master's degree in Statistics

PhD preferred

Tools

R

SAS

Python

CDISC SDTM ADaM

Job description

Cytel is seeking an Associate Director of Biostatistics to support or lead clinical trials for drug development within an FSP framework. You will contribute to study concepts, SAPs, protocols, and regulatory documents, while providing expert biostatistical input and oversight of external resources.

The role emphasizes advanced statistical methods, machine learning and collaboration across departments to drive efficiency and innovation in statistical analysis.