Travere Therapeutics
In rare for life.
Associate Director – Biostatistics
Location
California
Posted
5 days ago
Salary
$150K - $195K / year
Postgraduate Degree6 yrs expEnglish
Job Description
• Work closely with the Biometrics Project Lead in providing statistical support to clinical studies
• Serve as the lead statistician of late-stage trials and drive statistical strategy & execution
• Oversee statistical aspects of trials to ensure all requirements are met
• Provide statistical knowledge in study design, analysis, reporting, and interpretation
• Conduct statistical analyses and oversee external vendors
• Collaborate with cross-functional teams to ensure quality of Biometrics deliverables
• Contribute to the development of Biometrics-related SOPs and technical documents
• Research and apply new statistical methodologies as needed
Job Requirements
- M.S. in Statistics/Biostatistics is required, Ph.D. is preferred
- Minimum 6 years of relevant experience in the biopharmaceutical industry
- Hands-on experience as a Study Statistician (at least 4 years) or Lead Statistician (at least 2 years)
- Vendor oversight & management experience
- Knowledge of the drug development process
- Understanding of FDA and ICH requirements
- Extensive experience with study designs, power/sample size computations, (longitudinal) data analysis, and simulations
- Proficiency in SAS programming, experience with R preferred
- Experience with data pooling to support reports and publications
- Ability to manage multiple tasks with competing timelines
- Excellent communication and collaboration skills
Benefits
- premium health
- financial offerings
- work-life and well-being offerings
- wellness and employee support programs
- life insurance
- disability
- retirement plans with employer match
- generous paid time off