Embedded Biostatistics Director - Phase 3 Trials Lead

Cytel; Nashville (TN); On-site; USD 150,000 - 210,000; Full time

Job summary

Cytel in Nashville is seeking an Associate Director of Biostatistics dedicated to a major Pharma client, supporting trials with advanced statistical methods. You will lead statistical activities from protocol design to reporting and collaborate across cross-functional teams.

The role requires a Master’s in Statistics (PhD preferred), 7+ years of trial experience, and strong SAS/R skills; familiarity with EMA/FDA guidelines is a plus.

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 recent experience (≥3 years) 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 experience on Hematology studies preferred.
• Good understanding of the drug development process and cross-functional interfaces and experience supporting end-to-end trial delivery.
• Working knowledge of EMA/FDA/ICH guidelines and regulatory expectations for clinical trials and submissions.
• Proficient in SAS and/or R for QC of statistical outputs and collaboration with programming teams.
• Excellent and effective communication skills (clear, concise, and professional) and ability to interact effectively with cross-functional stakeholders and external partners.
• Strong organizational and project management skills.
• Demonstrated ability to work independently, take ownership and be accountable for study-level statistical activities and deliverables.

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

SAS

R

Communication skills

Project management

Cross-functional collaboration

End-to-end trial delivery

Adaptive design

Hematology experience

Machine learning knowledge

Education

Master’s degree in Statistics or related quantitative discipline

PhD preferred

Tools

SAS

R

Job description

Cytel in Nashville is seeking an Associate Director of Biostatistics dedicated to a major Pharma client, supporting trials with advanced statistical methods. You will lead statistical activities from protocol design to reporting and collaborate across cross-functional teams.

The role requires a Master’s in Statistics (PhD preferred), 7+ years of trial experience, and strong SAS/R skills; familiarity with EMA/FDA guidelines is a plus.