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Principal Biostatistician
Location
Massachusetts
Posted
26 days ago
Salary
$160K - $220K / year
Job Description
Job Requirements
- Master in Statistics, Biostatistics, or equivalent work experience preferred
- Excellent knowledge of English
- SAS® certification is preferred
- 5+ years in Pharmaceutical/Biotechnology industry or equivalent statistical consulting and SAS programming role preferred
- Strong experience with clinical study design development, analysis, and sample size determination
- Strong knowledge of ICH guidelines and other guidelines such as GCP, and 21 CFR Part 11 from different regulatory agencies including FDA, and EMEA
- Experience in developing statistical analyses reports, and in conducting statistical analyses and reporting for various trial level deliverables
- Knowledge of coding dictionaries (WHO, COSTART, ICD-9, MedDRA) and clinical reporting processes
- Knowledge of CDISC® related data models such as SDTM, and ADAM. Ability to develop ADAM model for analysis and reporting of clinical trial
- Ability and experience of delegating tasks and leading projects
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
- Wellness programs
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