What if the work you did every day could impact the lives of people you know? Or all of humanity?

At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our 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 quality and timeliness of deliverable 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 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 development and evaluation of in-vitro diagnostics (IVDs) and/or companion diagnostics (CDx)
Experience in the field 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 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.

The estimated base salary range for the Associate Principle Clinical Data Scientist - Statistical Programmer (Remote) role based in the United States of America is: $167,200 - $250,800. Should the level or location of the role change during the hiring process, the applicable base pay range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.

At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf