Embedded Biostatistics Lead — Phase 3 Trials

Cytel; Santa Fe (NM); On-site; USD 140,000 - 190,000; Full time

Job summary

Cytel is seeking an Associate Director of Biostatistics dedicated to a major Pharma client, embedding within their team to lead or support trials in drug development. You will apply advanced statistical methods and collaborate across functions to influence trial design and reporting.

Responsibilities include leading Phase 3 statistical activities, coordinating with cross-functional teams, overseeing programming and CROs, and delivering regulatory-ready analyses using SAS and/or R.

Qualifications

• Master’s degree in Statistics or related quantitative discipline.
• 7+ years of experience supporting clinical trials in pharma/biotech.
• Recent Phase II-III experience including SAP development and sample size calculation.
• Knowledge of adaptive design and group sequential methods.
• Experience with hematology studies preferred.

Responsibilities

• Lead statistical activities for assigned clinical trials from design to reporting.
• Represent Statistics on cross-functional trial teams.
• Oversight of internal programming and CRO contributions.
• Contribute to database lock, submission activities and safety reporting.
• Collaborate with stakeholders to develop study outputs in line with regulatory requirements.
• Use SAS and/or R for QC, inferential analyses, modelling, simulation, and exploratory analyses.

Skills

Statistical leadership

Cross-functional collaboration

Independent work

Regulatory communication

Education

Master's in Statistics

PhD preferred

Tools

SAS

R

SAP development

Job description

Cytel is seeking an Associate Director of Biostatistics dedicated to a major Pharma client, embedding within their team to lead or support trials in drug development. You will apply advanced statistical methods and collaborate across functions to influence trial design and reporting.

Responsibilities include leading Phase 3 statistical activities, coordinating with cross-functional teams, overseeing programming and CROs, and delivering regulatory-ready analyses using SAS and/or R.