Senior Biostatistician
Job Summary
Leading biostatistical efforts, the full-time Senior Biostatistician will manage clinical trial projects remotely, overseeing statistical analysis, developing study plans, and mentoring junior staff while ensuring compliance with regulatory standards.
Key responsibilities
- Manage projects to ensure timely completion of statistical tasks and communicate changes in scope to project management
- Develop and review statistical analysis plans, interim analysis plans, and programming specifications for clinical studies
- Assist in training new Biostatistics employees and mentor junior Biostatisticians to enhance team capabilities
Required qualifications
- Master's degree in Biostatistics, Statistics, or a related field
- At least 4 years of relevant biostatistics experience in a pharmaceutical or CRO environment
- Experience with CDISC, SDTM, and ADaM dataset mapping
- Familiarity with BLA/NDA submissions and regulatory representation preferred
- Therapeutic experience in transplantation, autoimmune diseases, or oncology is preferred
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