Biostatistician

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Job Summary:

As a Senior Biostatistician, you will lead the statistical design, analysis, and reporting of clinical trials and Real World Data (RWD) studies. You will collaborate cross-functionally with clinical, regulatory, data management, and programming teams, serving as a strategic partner throughout the study lifecycle

Key Responsibilities:

Oversight and co-ordination of statistical activities in clinical studies and regulatory

submissions. Provide statistical expertise in the design, planning, evaluation and

documentation of clinical trials and RWD studies. Tasks include but are not limited to:

Clinical and RWD study design discussions

Input to study protocols and sample size calculations

Develop Statistical Analysis Plan (SAP)

Prepare data standard and reporting specifications (ADAM and TLFs)

Conduct statistical programming (using SAS and R)

Perform statistical analyses and exploratory work e.g. modelling and simulation

Documentation of the results in statistical and clinical reports

Discuss results interpretation with customers

Support internal process development

Mentoring and supporting colleagues within the biostatistics and programming team

Project management and co-ordination of statistical deliveries for studies

Qualifications:

• Master of Science in Statistics or Mathematics
• Minimum 5 years of experience of statistical design and analysis of clinical and/or RWD studies
• Knowledge about statistical software (e.g., SAS, R)
• Ability to manage multiple projects and work both independently and collaboratively