Sr. Statistician – Chemistry, Manufacturing, And Controls (cmc)

Newyorkbioconnect

Base: $126,500.00 - $199,100.00; bonus/equity: eli...
Hybrid
Design of experiments (doe)
Statistical process control (spc)
Bayesian statistical framework
The incumbent is responsible for statistical analysis and evaluation of data to meet the needs of the Manufacturing Division supporting vaccine manufacturing processes

Job Summary

  • The incumbent is responsible for statistical analysis and evaluation of data to meet the needs of the Manufacturing Division supporting vaccine manufacturing processes.
  • The role includes designing experiments, analyzing stability studies, supporting scale-up and technology transfer, and preparing statistical content for regulatory submissions.
  • The company offers a comprehensive benefits package including medical, dental, vision, retirement plans, paid holidays, vacation, and flexible hybrid work arrangements.

Matching Summary

The incumbent is responsible for statistical analysis and evaluation of data to meet the needs of the Manufacturing Division supporting vaccine manufacturing processes.

Salary

Base: $126,500.00 - $199,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation

Skills & Requirements

Must-have

  • Design of Experiments (DoE)
  • Statistical Process Control (SPC)
  • Bayesian statistical framework
  • Mixed-effects models
  • CMC documentation support
  • Statistical software proficiency

Nice-to-have

  • Strong consulting skills
  • Excellent communication skills
  • Leadership and problem-solving
  • Cross-functional collaboration
  • Creative and original thinking

Key Requirements

  • MS in statistics or related field with 5 years experience
  • Experience in pharmaceutical vaccine manufacturing
  • Proficiency in at least two statistical software packages
  • Experience with CMC activities aligned with ICH guidelines
  • Experience in Bayesian statistics
  • Experience with mammalian cell culture and yeast fermentation

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter