Biostatistics Associate Director — Embedded in Global Trials

Cytel; Cheyenne (WY); On-site; USD 150,000 - 210,000; Full time

Job summary

Cytel is seeking an Associate Director of Biostatistics to provide statistical support and leadership for major pharma client trials within the Global Therapeutic Statistics group. You will help develop integrated analytical plans, design studies, and guide analyses from protocol to CSR.

You will apply advanced methods, including adaptive designs and count data techniques, while collaborating with data management, programming and clinical teams to ensure regulatory compliance and timely study

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 (≥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 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) from design to reporting.
• Represent Statistics on cross-functional trial teams and collaborate with stakeholders.
• Oversight of internal programming activities and CRO contributions.
• Contribute to or lead database lock, submission activities, safety reporting and regulatory responses.
• Collaborate with clinical, data management and programming teams to finalize outputs per regulatory requirements.
• Use SAS and/or R for QC, analyses, modelling, simulations and Exploratory analyses.
• Coordinate statistical activities across studies within the assigned project to ensure alignment and on-time delivery.

Skills

Statistical analysis

Communication

Project management

Independent work

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 provide statistical support and leadership for major pharma client trials within the Global Therapeutic Statistics group. You will help develop integrated analytical plans, design studies, and guide analyses from protocol to CSR.

You will apply advanced methods, including adaptive designs and count data techniques, while collaborating with data management, programming and clinical teams to ensure regulatory compliance and timely study