In this role you support Phase I–IV clinical studies as a Biostatistician embedded with a pharmaceutical client. You perform analyses to inform submissions and respond to Health Authority questions, collaborating closely with clinical and regulatory teams. You will contribute to study design, SAPs, and clinical study reports, while benefiting from Cytel’s training and support. This position offers impact through advanced statistical work and cross-functional collaboration in a fast-paced, client-focused environment. You help push clinical development forward and motivate teams to excel.
Responsibilities
Provide statistical support to clinical studies
Participate in study design discussions and sample size calculations
Review CRFs and data review guidelines; develop SAPs and TLG/effective analysis datasets
Perform statistical analyses and interpret results
Prepare clinical study reports, including integrated summaries for submissions
Communicate methodology and implications of decisions clearly to stakeholders
Key requirements
3+ years supporting clinical trials in pharmaceutical or biotech
Experience with protocol development, SAP, CDISC requirements, and ADaM
Solid SAS programming skills for QC of outputs and tables
Knowledge of R is a plus
Experience with regulatory submissions and integrated summaries
Strong external and internal relationship-building and excellent communication
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