Senior Biostatistics Lead — Clinical Trials

Cytel; Washington (District of Columbia); On-site; USD 150,000 - 230,000; Full time

Job summary

Cytel in the United States is seeking an Associate Director of Biostatistics dedicated to one of our major Pharma clients, leading statistical activities for Phase 3 trials and guiding analysis plans and regulatory submissions.

You will collaborate with clinical, data management and programming teams, oversee CRO work, and apply advanced methods, including adaptive designs and count data analyses, to deliver high-quality study outputs.

Qualifications

• 7+ years of experience supporting clinical trials in the pharmaceutical/biotech industry
• Experience with 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 in end-to-end trial delivery
• Working knowledge of EMA/FDA/ICH guidelines and regulatory expectations for trials and submissions
• Proficient in SAS and/or R for QC of statistical outputs and collaboration with programming teams
• Excellent communication and ability to interact with cross-functional stakeholders and external partners
• Strong organizational and project management skills
• Demonstrated ability to work independently and own study-level statistical activities

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 with stakeholders
• Oversight of internal programming activities and CRO contributions on trials and related activities
• Contribute to or lead other activities from a statistical perspective, including database lock and submission
• Collaborate with clinical, data management, programming and other stakeholders to finalize study outputs
• Use SAS and/or R for QC, inferential analyses, modelling, simulations and exploratory analyses
• Coordinate statistical activities across studies within the assigned project for aligned objectives and on-time delivery

Skills

Statistical methods

Machine learning

Education

Master’s degree in Statistics or related quantitative discipline

PhD preferred

Tools

SAS

R

Job description

Cytel in the United States is seeking an Associate Director of Biostatistics dedicated to one of our major Pharma clients, leading statistical activities for Phase 3 trials and guiding analysis plans and regulatory submissions.

You will collaborate with clinical, data management and programming teams, oversee CRO work, and apply advanced methods, including adaptive designs and count data analyses, to deliver high-quality study outputs.