Embedded Biostatistics Associate Director - Trial Strategy

Cytel; Montpelier (VT); On-site; USD 150,000 - 190,000; Full time

Job summary

Cytel seeks an Associate Director of Biostatistics to work embedded within one of our FSP clients, leading statistical support for drug development programs. You will influence study concepts, SAPs, and regulatory deliverables while guiding external teams.

The role emphasizes modern analytics, including machine learning, to accelerate trials and deliver high-quality results. Ideal candidates hold a Master’s in Statistics or related fields (PhD preferred) with 7+ years in biotech/pharma, strong

Qualifications

• Master’s degree in Statistics or a related field is required. PhD preferred.
• Experience with a broad array of statistical approaches and modeling in biotech/pharma.
• Strong understanding of regulatory guidelines on drug development and submissions.
• Solid programming skills in R, SAS, and Python.
• Familiarity with CDISC, SDTM, and ADaM specifications is a plus.
• Proven vendor management experience and collaboration with CROs.

Responsibilities

• Support statistical strategy for assigned drug programs and input to development plans and protocols.
• Oversee production of biostatistics deliverables (TFLs, analyses) by external resources.
• Provide statistical input in protocols, CSRs, and manuscripts.
• Review randomization procedures and production of randomization lists.
• Review study documents to ensure statistical requirements are met.
• Oversee outsourced CRO activities to ensure quality and timeliness.
• Develop innovative tools and methodologies for statistical analysis.
• Contribute to department strategies and cross-functional initiatives.

Skills

Biostatistics

Statistical analysis

Machine learning

Deep learning

Regulatory knowledge

Vendor management

Communication skills

R

SAS

Python

Education

Master's degree in Statistics or related field

PhD preferred

Tools

R

SAS

Python

Job description

Cytel seeks an Associate Director of Biostatistics to work embedded within one of our FSP clients, leading statistical support for drug development programs. You will influence study concepts, SAPs, and regulatory deliverables while guiding external teams.

The role emphasizes modern analytics, including machine learning, to accelerate trials and deliver high-quality results. Ideal candidates hold a Master’s in Statistics or related fields (PhD preferred) with 7+ years in biotech/pharma, strong