Cardinal Health Senior Biostatistician in Milpitas, California

Supporting the Cordis Cardinal Health business with a focus on Cardiovascular & Peripheral artery disease, the Senior Biostatistician will provide statistical input into the clinical development of devices for treatment of cardiovascular disease. The Senior Biostatistician will work with the clinical team in designing clinical studies, SAS programming, leading/authoring the statistical analysis plan, ensuring accuracy and facilitating the implementation of statistical analyses, providing statistical input to clinical study reports, performing statistical functions for FDA / Regulatory submission related activities, and providing input in the preparation of scientific presentations and manuscripts. The Senior Biostatistician will participate in process improvement, training, standards development and enhancing statistical technical expertise. The Senior Biostatistician will be involved in communication and interaction with members from clinical study teams, contract research organizations (CROs) clinical data management, clinical trials management, regulatory affairs, medical affairs, quality, medical writing, and R&D. The Senior Biostatistician will work with external partners including key opinion leaders and may work with external regulatory agencies and advisory committees.

Job Description

  • Works with clinical and cross-functional stakeholders to identify and support business opportunities, goals, or objectives
  • Determines if objectives can be met using analytical approach and develops hypotheses
  • Identifies key data requirements and acquires data
  • Harmonizes, rescales, and cleans clinical data for statistical techniques
  • Develops and leverages best statistical practices and methodologies to support objectives of clinical studies
  • Provides analytic insight on biostatistical strategies utilized in competitive clinical studies
  • Provides biostatistical support to clinical project teams across multiple therapeutic areas and geographical locations
  • Interprets clinical outcomes and identifies trends and issues in clinical data
  • Demonstrates ability to clearly and concisely communicate complex information to a variety of audiences and mediums

Qualifications

  • Bachelor’s Degree in related field required
  • Advanced Degree (Master’s Degree or PhD) in related field preferred
  • 4+ years of experience in related field, including relevant clinical trial experience in the industry (sponsor or CRO) or academic setting

What is expected of you and others at this level

  • Applies advanced knowledge and understanding of statistical concepts, principles, and technical capabilities to manage a wide variety of clinical projects
  • Participates in the development of policies and procedures to achieve specific goals
  • Recommends new practices, processes, metrics, or models
  • Works on or may lead complex projects of large scope
  • Projects may have significant and long-term impact
  • Provides solutions which may set precedent
  • Independently determines method for completion of new projects
  • Receives guidance on overall project objectives
  • Acts as a mentor to less experienced colleagues

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.