Principal Biostatistician - Remote or Deerfield, IL
A Principal Biostatistician is responsible for independently planning and managing project deliverables and study-level analysis and reporting activities and for providing statistical support for clinical trials.
- Apply knowledge of statistics, statistical programming, and pharmaceutical regulations to drug development projects
- Participate in the design and review of clinical protocols, including preparation of statistical sections, sample size calculations, randomization, and study design
- Prepare and review statistical analysis plans (including shell tables, listings, and figures)
- Prepare and review programming specifications used in creating derived datasets, tables, listings, and figures
- Perform efficacy and safety analyses for clinical trials data and participate in validation and quality checks for statistical output
- Implement and support CDISC, ICH, and other regulatory standards
- Review CRFs, database specifications and database validation checks
Project Management Responsibilities:
- Plan and manage project and study-level analysis and reporting activities
- Communicate with clients and colleagues on statistical issues and project status
Standard Operating Procedures (SOPs):
- Be familiar with and follow departments SOPs
- Assist in creating, revising and review of departments SOPs
- Assist in preparing monthly revenue reports for biostatistics
- Assist with RFP/RFI completing and attend sales meetings as requested
- PhD or Master’s degree in Statistics or a closely related field
- A minimum of 5-7 years of experience as a statistician in pharmaceutical development and SAS programming for statistical analysis.
- Candidate must have experience in clinical trial design and must be familiar with regulatory requirements.
- Excellent oral and written communication skills, organizational skills, and attention to detail are required.
- CDISC experience required
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