Associate Principle Clinical Data Scientist - Statistical Programmer (Remote)

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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