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).

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.

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

Principal Biostatistician, Clinical Trials

Key skills