Minimal supervision; represent Biostatistics for complex studies.
Contribute to design of early/late-stage protocols across therapies.
Draft protocols/amendments; develop SAPs; analyze interim and final reports.
Support submissions: design, analysis and reporting of safety and efficacy summaries.
Attend study/project meetings and provide statistical input.
Lead in BDM; coordinate study deliverables with statisticians and data managers.

🎯 Requirements

MS or PhD in Statistics or Biostatistics.
PhD + 6 yrs or MS + 11 yrs clinical trial exp.
Hands-on Phase I–III clinical trials; SAS programming; R desirable.
Excellent oral and written communication skills.
Regulatory submissions experience in US, Europe, Japan and RoW desirable.

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