Lead Biostatistician

US, US, CA - San Diego

Minimum Level of Education Required: Masters Degree

Percentage of Travel: Up to 25%

Location: CA - San Diego

Ref#: 100071

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Job Description

Our Lead Biostatistician is key in supporting all areas of clinical database management and biostatistical output for NuVasive, a service provider of intraoperative neuromonitoring and manufacturer of spinal and specialized orthopaedic devices. The Lead Biostatistician will contribute to protocol and post-market clinical follow up (PMCF) plan generation, data collection, data quality initiatives, database management, data reporting, data analysis, results interpretation, and reporting in all relevant internal and external venues.


Essential Responsibilities:

·        Responsible for study design, sample size justifications, and statistical analysis planning for post-market studies and plans.

·        Oversee database management team and develop standard operating procedures (SOPs) regarding data management and quality processes.

·        Organize and process historical data sources, in collaboration with organizational priorities and clinical scientists/medical writers.

·        Strategize and fulfill predictive analytic programs from clinical and business datasets.

·        Oversee data collection and reporting on multicenter patient outcomes registry.

·        Develop and implement organizational SOPs for statistical guidelines in protocol and data collection planning and execution.

·        Achieve statistical excellence, producing clear, accurate, and creatively produced and written work for a variety of audiences.

·        Demonstrate a high level of product and procedure knowledge to support research-related questions and independently provide internal/external training on statistics as necessary.

·        Provide training, mentorship, and guidance for junior team members in all aspects of biostatistics and database management.

·        Develop and implement corporate procedures for medical writing.

·        Assist research and other project team members in additional responsibilities as required.

Basic Qualifications
  • Master’s degree in Statistics or related discipline
  • 5+ years of experience as a biostatistician in a healthcare-related field/industry
  • Strong understanding and comprehension of statistical and general medical terminology
  • Proven experience of data management, protocol development, and data analyses
  • Required: Strong proficiency with statistical (R, JMP, SAS, or equivalent) and database management software.
Preferred Qualifications
  • PhD
  • Experience in a clinical or industry setting with study experience focused on Spine, Orthopedics, or Medical Devices
  • Biostatistical leadership role experience.
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company's portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com. 
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