Responsibilities
- Collaborate with statistical colleagues and study personnel to provide input to statistical analysis plans, write reports, communicate results, and assist/respond to regulatory queries.
- Select statistical methods for data analysis, author analysis plan sections, and conduct analysis once the reporting database is created.
- Collaborate with data management on planning and implementing data quality assurance plans.
- Maintain proficiency with SAS programming and statistical methodology; apply new and varied methods.
- Justify chosen methods and implement previously outlined analysis plans.
- Conduct peer-review of statistical work products.
- Use current technologies and tools for clinical trial analysis.
- Assist communication of study results via regulatory submissions and manuscripts; communicate one-on-one with key customers.
Therapeutic Area and Systems Knowledge
- Understand relevant disease states to enhance customer focus and collaboration.
- Ensure replication of tools and systems (as applicable) and stay informed of technological advances.
Regulatory and Quality Compliance
- Perform work in full compliance with assigned curriculum(s) and follow applicable corporate/medical/local/departmental policies, procedures, processes, and training.
Basic Qualifications
- Masterβs degree in Statistics/Biostatistics/MSPH (concentration in Statistics or Biostatistics) or relevant areas.
- 7+ years of statistical analysis/programming experience.
Additional Skills/Preferences
- Proficiency in SAS, R, Spotfire, etc.
- Interpersonal/teamwork skills; technical growth.
- Self-management for timely completion of competing deliverables.
- Creativity/innovation; problem-solving and attention to detail.
Benefits (as stated)
- Company bonus (FTE eligible).
- 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.