Senior Biostatistician (Clinical Trial Experience Required)
Covington, Kentucky, United States
R
USD 136K-241K (estimate) Senior-level Full Time
Tasks
- Act as primary statistical contact
- Assist with SOP development
- Conduct power analysis and sample size estimation
- Contribute to database design and data edit considerations
- Determine endpoints and outcomes
- Develop and review ADaM specifications
- Develop and review SDTM specifications
- Develop and review Statistical Analysis Plans
- Develop and review interim analysis plans
- Develop and review randomization plans and programs
- Develop mock tables listings and figures
- Develop randomization and blinding procedures
- Develop statistical methods and results text
- Develop statistical protocol methods
- Develop study bid scope changes
- Ensure work complies with CTI SOPs and GCP ICH guidelines
- Identify scope changes
- Maintain statistics documents and eTMF filings
- Manage project statistics timelines
- Mentor junior biostatisticians
- Participate in departmental meetings
- Perform independent statistical programming
- Plan and design clinical studies
- Present study execution tasks at capability presentations
- Review case report forms and completion instructions
- Review team member programming
- Train biostatistics employees
- Validate developer programs
Perks/Benefits
- Health benefits
- Hybrid work from home
- Leadership courses
- Mentoring program
- Paid parental leave
- Tuition reimbursement
- Vacation packages
Skills/Tech-stack
ADaM | Analysis Plan | Biostatistics | Blinding | CDISC | Case Report Forms | Clinical trial | Data cleaning | Database Design | ETMF | Interim analysis | Mock tables listings and figures | Power analysis | Randomization | SDTM | Sample Size | Sample size estimation | Size estimation | Statistical Analysis | Statistical Analysis Plan | Statistical programming | Tables Listings and Figures
Education
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