Senior Biostatistician

As a Senior Biostatistician you will provide statistical leadership throughout the clinical trial lifecyclefrom 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 IIIV 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.

Employment Type : Employee
Experience: years
Vacancy: 1