Senior Biostatistician I

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ICON

Ability to perform Study Statistician role with minimal supervision.
Demonstrates strong statistical expertise with a good understanding of more complex design of experiments and inference methodologies (where applicable awareness/knowledge of Bayesian, Futility & Predictive Inference, Estimands, Missing Data etc.).
Where required, ability to actively participate in matrix team meetings.
Applies standard processes to tasks, ensuring that deliverables are accurate, high quality and met according to agreed timelines.
Extensive working knowledge of GxP, ICH, internal GSK processes and external regulations (as applicable).
Quality Control (QC) of other people's work under supervision.
Under supervision:
- Supports design, analysis and interpretation, uses a wide range of statistical approaches and/or applicable software to explore options.
- Authors analysis plans and prepares statistical inputs to key documents and presentation materials.
- Contributes to the development of statistical strategy at a study-level, which may be shared with stakeholders.

Master’s degree in statistics or biostatistics required.
Minimum of 5 years of biostatistical experience desired.
Clinical experience is mandatory.
Exhibit expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
Thorough knowledge of and experience with CDISC standards is desired.
Demonstrate ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study.
Auto-immune and/or oncology clinical study background is a plus.
Experience in managing vendors is a plus.

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