Statistical expertise for engineers and scientists
The Principal CMC Biostatistician is responsible for providing statistical support for a wide range of activities pertaining to pharmaceutical manufacturing
Job Summary
The Principal CMC Biostatistician is responsible for providing statistical support for a wide range of activities pertaining to pharmaceutical manufacturing.
Home-based remote working opportunities, work/life balance, and flexible schedules are offered.
Collaborate with multi-disciplinary project teams to establish project objectives and timelines in a dynamic, science-focused work environment.
Matching Summary
The Principal CMC Biostatistician is responsible for providing statistical support for a wide range of activities pertaining to pharmaceutical manufacturing.
Salary
Base: $105,800.00 - $294,800.00; Bonus/Equity: Not specified; Benefits: Not specified
Skills & Requirements
Must-have
statistical support for CMC
statistical analysis plans and reports
statistical expertise for engineers and scientists
modeling and visualizations of data
regulatory submission experience
R or JMP expertise
Nice-to-have
pro-active and independent work
good statistical practice advocacy
design of experiments
Bayesian methods
quality by design
Key Requirements
Ph.D. in Statistics, Biostatistics, or related field with 5+ years industry experience
M.S. in Statistics, Biostatistics, or related field with 7+ years industry experience
At least 3 years in statistical support of CMC
Demonstrated ability to work pro-actively and independently
Able to effectively communicate ideas and statistical concepts
Understanding of regulatory guidance pertaining to drug manufacturing