Fsp Principal Biostatistician, Safety Analytics

Ivivamedical

Home-based, US
Base: $105,800.00 - $294,800.00; bonus/equity: not...
Fully remote
Statistical support for clinical trials
Adam/tfl dataset review
Safety analytics expertise
The Principal Biostatistician is responsible for providing statistical support for Phase 1, 2 and 3 pharmaceutical clinical trials in patients, focusing on safety endpoints and outcomes

Job Summary

  • The Principal Biostatistician is responsible for providing statistical support for Phase 1, 2 and 3 pharmaceutical clinical trials in patients, focusing on safety endpoints and outcomes.
  • The role offers home-based remote working opportunities with a focus on work/life balance and flexible schedules.
  • The position includes collaborating with motivated, high-performance statistical and research teams and contributing to regulatory documents such as NDA and DSURs.

Matching Summary

The Principal Biostatistician is responsible for providing statistical support for Phase 1, 2 and 3 pharmaceutical clinical trials in patients, focusing on safety endpoints and outcomes.

Salary

Base: $105,800.00 - $294,800.00; Bonus/Equity: Not specified; Benefits: Range of health and welfare and/or other benefits

Skills & Requirements

Must-have

  • Statistical support for clinical trials
  • ADaM/TFL dataset review
  • Safety analytics expertise
  • R/SAS programming skills
  • Regulatory submission experience
  • Collaboration with cross-functional teams

Nice-to-have

  • Flexible work schedule
  • Home-based remote working
  • Technical training and development
  • Leadership in DMC biostatistics
  • Proactive and independent work style

Key Requirements

  • PhD in Statistics or related field with 5+ years experience
  • MS in Statistics or related field with 7+ years experience
  • At least 5 years Phase 1-3 clinical trial experience
  • Experience with CDISC standards including SDTM and ADAM
  • Understanding of ICH GCP and ICH E9 guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter