NMDP

Principal Biostatistician, Clinical Trials

NMDP

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Lead

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
SASRstatistical analysisclinical trial methodologystatistical conceptsresearch study designstatistical methodsdata managementanalytical skillsquality control
Soft Skills
mentoringadvisingproblem solvingdecision makingcommunicationcoachingcollaborationinput provisionproactive advisingexplanation of concepts
Certifications
PhDMaster's degree