Senior Biostatistician

As a Senior Biostatistician you will provide statistical leadership throughout the clinical trial lifecycle—from protocol development and study design through analysis, interpretation, and regulatory documentation. For assigned studies, you will shape the statistical strategy, including endpoints, estimands, sample size, randomization, and risk-based design, while serving as a trusted partner to internal teams and clients. This role combines technical expertise, client engagement, and strategic thinking, with a direct impact on clinical development decisions.

Key Responsibilities

• Provide statistical leadership across Phase II–IV clinical studies.

• Develop statistical and analytical strategies for clinical trials, including:

- Sample size calculations

- Randomization strategies

- Estimand definitions

• Author Statistical Analysis Plans (SAPs) and review tables, figures, and listings (TFLs).

• Review Clinical Study Protocols (CSPs) and Clinical Study Reports (CSRs).

• Review and approve programming specifications, statistical outputs, and analysis datasets prepared by statistical programmers.

• Present and defend statistical decisions in client meetings.

Required Qualifications

• University degree in Statistics, Mathematics, or a related quantitative or scientific discipline, such as Physics, Chemistry, Biostatistics, or Epidemiology.

• At least three years of experience in clinical trial statistics.

• Experience developing or reviewing SAPs, CSPs, CSRs, and TFLs.

• Working knowledge of GCP, ICH E3/E6/E9, CDISC standards, and regulatory expectations.

• Advanced statistical expertise in areas such as mixed-effects regression models, multiple imputation, adaptive designs, and/or the estimand framework.

• Proficiency in SAS is required.

• Experience with Python, R, Git, and SharePoint is preferred.

• Excellent written and verbal English skills; business fluency is mandatory.