Operate with minimal supervision and represent Biostatistics at project level.
Design early/late-stage protocols across multiple areas; draft amendments.
Develop and write statistical analysis plans; perform analyses for interim/final reports.
Support submission activities, including integrated safety/efficacy summaries.
Attend study team or project meetings to contribute statistics.
Lead study deliverables scheduling within the Biostatistics/Data Management team.

🎯 Requirements

MS or PhD in Statistics or Biostatistics
PhD + 6 years (or MS + 11 years) clinical trial experience in biotech/pharma
Hands-on Phase I/II/III trials; SAS programming; R desirable
Excellent oral and written communication skills
Regulatory submissions experience desirable (US/Europe/Japan)

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