Associate Director, Biostatistics — Clinical Trials Lead

Cytel; United States; On-site; USD 180,000 - 230,000; Full time

Job summary

Cytel is seeking an Associate Director of Biostatistics to work embedded with a major Pharma client within Cytel's Global Therapeutic Statistics group. You will lead statistical activities for late-stage trials and influence study design, analyses, and regulatory readiness.

You will leverage SAS and R to perform QC, analyses, and modeling, while collaborating across clinical, data management, and programming teams to ensure timely, compliant deliverables.

Qualifications

• Master’s degree in Statistics or related quantitative discipline; PhD preferred.
• 7+ years of experience supporting clinical trials in pharma/biotech.
• Solid experience in Phase II–III studies, including SAP development, sample size calculation, and TLF review.
• Strong knowledge of adaptive design, group sequential and statistical methods of count data.
• Prior Hematology study experience preferred.
• Working knowledge of EMA/FDA/ICH guidelines for trials and submissions.
• Proficient in SAS and/or R for QC of statistical outputs and collaboration with programming teams.

Responsibilities

• Lead statistical activities for assigned Clinical Trials (mainly 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.
• Coordinate statistical activities across studies within the assigned project, ensuring alignment of objectives, consistency of approach, and on-time delivery

Skills

Statistical analysis

Clinical trials

Adaptive design

Group sequential

Cross-functional collaboration

Regulatory knowledge

Communication skills

Education

Master’s degree in Statistics

PhD preferred

Tools

SAS

R

SAP

Job description

Cytel is seeking an Associate Director of Biostatistics to work embedded with a major Pharma client within Cytel's Global Therapeutic Statistics group. You will lead statistical activities for late-stage trials and influence study design, analyses, and regulatory readiness.

You will leverage SAS and R to perform QC, analyses, and modeling, while collaborating across clinical, data management, and programming teams to ensure timely, compliant deliverables.