Associate Principle Clinical Data Scientist – Statistical Programmer (Remote)

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our

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efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.

Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world-changing projects, you will do more and become more than you ever thought possible.

Position Summary

Illumina seeks an experienced Clinical Data Scientist (CDS) at the Associate Principal level to provide data science and statistical programming expertise and leadership in data curation, analysis, and reporting for clinical studies used to achieve regulatory approval of in vitro diagnostic (IVD) and companion diagnostic assays in the US and internationally (including FDA PMA, 510(k), and equivalent EU approval). This position interacts closely with Biostatistics, Bioinformatics, Clinical Affairs, and Clinical Data Management.

Responsibilities

 

  • Drive innovation and provide strategic leadership and road mapping to the Clinical Data Science function
  • Serve as the cross-functional Clinical Data Science (CDS) Lead for CDx projects/studies and effectively communicate with internal/external stakeholders
  • Strategize and lead the planning and execution of programming activities to ensure the quality and timeliness of deliverables across projects
  • Drive functional and cross-functional initiatives, develop analysis and reporting standards, departmental SOPs/Work Instructions, and best practices
  • Strategize and lead the team development of standard and innovative programming tools/applications
  • Represent Clinical Data Science team and engage cross-functional teams to progress Clinical Data Science related tasks with proven influencing skills
  • Provide programming technical solutions to complex, significant, and unique tasks
  • Develop specifications and create/validate clinical analysis datasets and outputs that meet internal statistical analysis needs, industry regulations, and best practices
  • Develop, document, and maintain reusable programming code
  • Manage programming systems and tools in compliance with Good Clinical Practices, regulatory requirements, and industry standards
  • Lead internal Clinical Data Science meetings and Clinical Data Science related meetings with teams outside
  • Develop CDS presentations or training for different areas in the company as SME
  • Serve as a mentor for junior staff within Clinical Data Science

Listed responsibilities are of the usual duties associated with the position, but not an exhaustive list. Changes to individual responsibilities may occur due to business needs.

 

Requirements

 

  • Bachelor’s degree in life science, health-related science, bioinformatics, statistics, computer science, data science, engineering or related field
  • Expert in using SAS or R to develop reusable code for data analysis and reporting and to create innovative tools for automating tasks; demonstrated proficiency in Python is a plus
  • Demonstrated success in providing leadership in a regulated environment and in implementing automation solutions for process efficiency
  • Experience working with clinical trial data and familiar with clinical data standards (CDISC SDTM/ADaM)
  • Experience working with genomics data
  • Expert knowledge in areas of statistics programming relevant to the development and evaluation of in-vitro diagnostics (IVDs) and/or companion diagnostics (CDx)
  • Experience in the fields of genetics, oncology, bioinformatics, or knowledge of NGS technology is a plus.
  • Experience in data visualization using JMP, Tableau, or other tools is a plus
  • Excellent organizational, collaboration, and communication skills
  • Knowledge of and experience in CLSI is a plus
  • Typically requires a minimum of 15 years of related work experience with a Bachelor’s degree; or 12 years and a Master’s degree; or equivalent work experience.

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