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Hiring companyEDETEK
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Senior Biostatistician
India Full-time Remote
About the role
Clinical Biostatistics Team provides statistical expertise for oncology clinical trials across all phases. The Senior Biostatistician leads study design, statistical analysis planning, data interpretation, and DMC activities while collaborating with sponsors, data managers, and regulatory teams. Remote work from United States, India, Ukraine, Bulgaria, Poland or Romania.
What you’ll do
- Provide statistical support from study start-up to final reporting
- Develop and review statistical analysis plans and protocols
- Collaborate with sponsors and cross‑functional teams on study design and analysis
- Review statistical outputs ensuring quality and regulatory compliance
- Support interim analyses, safety reviews, and DMC meetings
- Mentor junior statisticians and contribute to process improvements
What you’ll bring
- Master's degree or PhD in Statistics or Biostatistics
- 5-8+ years biostatistics experience in clinical research
- CRO experience
- Oncology clinical trial experience
- DMC/IDMC activity experience
- Proficiency in SAS
- Knowledge of ICH/GCP regulations
- Familiarity with CDISC standards
Skills
Statistical analysisClinical trialsOncologySAS programmingCDISC standardsSurvival analysisRegulatory compliance
Benefits
- Medical, vision and dental insurance
- 401K plan
- Paid vacation and sick days
- Corporate holidays
- Employee assistance program
Education
Master's degree or PhD