Biostatistician or Sr. /Prin. Biostatistician - Remote or Deerfield, IL
Location: Frankfort, IL
A Biostatistician/Sr. 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 3-6 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 preferred
Advanced Group is proud to be an Equal Opportunity Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, ancestry, marital or veteran status.
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