Biostatistics Associate Director — Clinical Trials Lead

Cytel; Dover (DE); On-site; USD 140,000 - 190,000; Full time

Job summary

Cytel Inc. is seeking an Associate Director of Biostatistics dedicated to one of our major pharma clients, providing statistical leadership for late-stage trials and advanced analyses within the Global Therapeutic Statistics group.

You will lead statistical activities from protocol design through reporting, collaborate with cross-functional teams, oversee CRO contributions, and ensure regulatory readiness. Proficiency in SAS or R and strong project management are essential.

Qualifications

• Master’s degree in Statistics or related quantitative discipline; PhD preferred.
• 7+ years of experience supporting clinical trials in the pharmaceutical/biotech industry.
• Solid experience in Phase II–III studies, including SAP development, sample size calculation, and TLF review.

Responsibilities

• Lead statistical activities for assigned Clinical Trials (Phases 3) independently from protocol design to reporting of results.
• Represent Statistics function on cross-functional trial teams and collaborate effectively with all cross-functional stakeholders.
• Oversight of internal programming activities and/or CRO contributions on assigned clinical trials and other activities.
• Contribute to or lead other activities from a statistical perspective as appropriate, including database lock and submission activities, safety reporting, adhoc requests and respond to regulatory questions.
• Collaborate closely with clinical, data management, programming, and other stakeholders to develop and finalize study outputs in line with regulatory and protocol requirements
• Use SAS and/or R for purposes like QC of datasets and deliverables, inferential statistical analyses, modelling/simulation, exploratory analyses etc.

Skills

Communication skills

Project management

Independence / ownership

Cross-functional collaboration

Education

Master’s degree in Statistics or related field

PhD preferred

Tools

SAS

R

Job description

Cytel Inc. is seeking an Associate Director of Biostatistics dedicated to one of our major pharma clients, providing statistical leadership for late-stage trials and advanced analyses within the Global Therapeutic Statistics group.

You will lead statistical activities from protocol design through reporting, collaborate with cross-functional teams, oversee CRO contributions, and ensure regulatory readiness. Proficiency in SAS or R and strong project management are essential.