- Lead the program-level biometrics team, including statisticians, data managers, and statistical programmers.
- Provide statistical input to strategic planning, study design, protocol development, sample-size calculations, CRFs, results interpretation, and clinical study reports.
- Address questions from regulatory agencies and contribute to global Health Authority documents and interactions.
- Promote research into advanced and innovative statistical methods for clinical studies.
- Author and develop statistical analysis plans and coordinate specifications for derived variables and templates for statistical tables, figures, and listings.
- Guide study teams on statistical activities and collaborate with data managers to support high-quality data.
- Work with cross-functional teams and vendors to meet project deliverables and timelines.
- Oversee CRO and vendor procedures, deliverables, accuracy, and timelines.
- Coordinate statistical analyses for investigator brochures, DSUR updates, periodic safety updates, and ad hoc requests.
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