Principal Biostatistician, Clinical Trials
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Job Description
Lead life‑saving clinical research as a Principal Biostatistician at NMDP. Mentoring biostatistics team and providing statistical support for clinical trials.
Responsibilities:
- Mentor, advise, review and leverage statistical expertise; develop complex analysis strategies and execute them using efficient programming techniques (software: SAS, R).
- Share knowledge and provide input to analysis plans, protocol design, statistical reports, statistical sections of clinical reports.
- Act as a proactive advisor for all types of analysis from the proposal process through the project life cycle.
- Review analysis data sets and quality control all types of statistical analysis deliverables.
- Coach and mentor junior members of the department.
- Execute intricate statistical analyses and provide input to statistical reports.
- Investigate novel approaches for designing and analyzing clinical research studies.
- Act as primary statistician on assigned projects from initial protocol design to final submissions to regulatory bodies.
- Review and provide input on case report forms (CRFs), database validation checks, and CRF completion instructions.
- Produce randomization schedules; lead blinding and unblinding processes.
- Develop and review Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs).
Requirements:
- PhD degree in relevant field with 5+ years in statistical design and analysis of clinical or biomedical studies or Master’s degree in relevant field with 8+ years of experience.
- Knowledgeable and experienced in clinical trial methodology.
- Experience and knowledge of clinical data management processes and tools (Medidata Rave and Veeva preferred).
- Demonstrated practical understanding of fundamental statistical concepts and methodologies.
- Proven knowledge of research study design methods, independent problem solving, decision making, and principles, concepts, methods, and standards of statistical analyses.
- Demonstrated ability to explain statistical concepts to non-statisticians to enhance their understanding of the analytical approach.
- Proficiency in statistical methods used to design and assess outcomes of clinical trials.
- Strong research and analysis skills including an understanding of scientific/therapeutic research in general.
- Advanced analytical skills, including high-level experience with SAS.
Benefits:
- NMDP offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits.
- Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information: NMDP Benefit Information
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