Senior Biostatistics Lead — Global Pharma Trials

Cytel; Concord (NH); On-site; USD 150,000 - 190,000; Full time

Job summary

Cytel is seeking an Associate Director of Biostatistics to lead statistical activities for major Pharma trials in a sponsor-dedicated role. You will work embedded with a global client, guiding development plans, SAPs, and regulatory submissions while applying advanced statistical methods and machine learning approaches.

You will collaborate across functions, oversee programming and CRO contributions, and ensure high-quality study outputs in line with regulatory expectations.

Qualifications

• Master’s degree in Statistics or related field; PhD preferred.
• 7+ years of experience in supporting clinical trials.
• Strong experience in Phase II-III studies and SAP development.
• Proficient in SAS and/or R for QC and analyses.
• Good understanding of EMA/FDA guidelines and regulatory expectations.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Lead statistical activities for assigned clinical trials (mainly Phases 3) from protocol design to reporting of results.
• Represent Statistics on cross-functional trial teams and collaborate with stakeholders.
• Oversight of internal programming activities and CRO contributions on trials and related activities.
• Contribute to or lead database lock, submissions, safety reporting, and regulatory responses.
• Collaborate with clinical, data management, programming, and other stakeholders to finalize study outputs.
• Coordinate statistical activities across studies to ensure alignment and on-time delivery.

Skills

Statistical analysis

SAS and R

Adaptive design

Clinical trials

Lead statistical activities

Communication skills

Project management

Education

Master’s degree in Statistics or related quantitative discipline

PhD preferred

Tools

SAS

R

Job description

Cytel is seeking an Associate Director of Biostatistics to lead statistical activities for major Pharma trials in a sponsor-dedicated role. You will work embedded with a global client, guiding development plans, SAPs, and regulatory submissions while applying advanced statistical methods and machine learning approaches.

You will collaborate across functions, oversee programming and CRO contributions, and ensure high-quality study outputs in line with regulatory expectations.