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 (both SDTM and ADaM) 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 Standard Operating Procedures (SOPs)
- Assist in creating, revising and review of department SOPs
- Assist in preparing monthly revenue reports for biostatistics
- Assist with RFP/RFI completion and attend sales meetings as requested by Business Development
- Performs other duties as requested by management
The ideal candidate should have an advanced degree (MS or PhD) in Statistics or a closely related field, with a minimum of 5 (PhD) or 7 (MS) years of experience in pharmaceutical development and SAS programming for statistical analysis. Candidate must have experience in clinical trial design and must comply with regulatory requirements. Excellent oral and written communication skills, organizational skills, and attention to detail are required.
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This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
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