Senior Manager Biostatistician Consultant Remote in US (24 months contract)
Related skills
r sas biostatistics clinicaltrials regulatorysubmissions๐ Description
- Design early/late-stage protocols across multiple therapeutic areas; draft amendments.
- Develop and write Statistical Analysis Plans; perform analyses for interim and final regulatory reports.
- Support submission activities, including design and reporting of integrated safety and efficacy summaries.
- Attend study team meetings and contribute to deliverables with statisticians and data managers.
- Lead within the BDM department to organize study deliverables with cross-functional partners.
๐ฏ Requirements
- MS or PhD in Statistics or Biostatistics.
- PhD +4 years (or MS +9 years) clinical trial experience in biotech/pharma.
- Hands-on Phase I/II/III clinical trial experience and SAS programming; R programming desirable.
- Excellent oral and written communication skills.
- Experience with regulatory submissions in US, Europe, Japan, and RoW desirable.
๐ Benefits
- Global CRO with focus on quality and professional development.
- Client-facing role with independence and high-trust collaboration.
- Supportive culture and opportunities for career growth.
- Longstanding company with 28+ years in the field and global reach.
- Equal opportunity employer emphasizing diversity and inclusion.
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