Sr. Staff or Sr. Manager Clinical Data Scientist (Remote) at Illumina, Inc. in San Diego, California

Job Description:

Position Summary

Illumina seeks an experienced Clinical Data Scientist (CDS) at the Sr. Staff or Senior Manager level to provide data science and statistical programming support in data curation and analysis 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

• Provide statistical programming leadership for companion diagnostic clinical studies in data analysis and reporting


• 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


• Maintain complete and auditable programming documentation


• Engage cross functional teams to progress Clinical Data Science related tasks with proven influencing skills


• Lead process improvement initiatives and development SOPs and best practices


• Experience managing programming systems and tools in compliance with Good Clinical Practices, regulatory requirements, and industry standards


• Manage and develop a CDS team, providing guidance, performance reviews and recruiting (applicable to Senior Manager)

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


• Experience in a manager or lead role independently handling clinical studies and leading a team of data scientists for various clinical studies preferred


• Demonstrated proficiency in using SAS or R and other programming languages (Python, JMP) to develop reusable code for data analysis and to create tools for automating tasks


• Experience working with clinical trial data or Omics data or biosample data


• Experience in the field of genetics, oncology, bioinformatics, or knowledge of NGS technology is a plus.


• Experience with clinical trials involving companion diagnostics is a plus


• Excellent verbal and written communication skills


• Able to proactively identify and address areas of inefficiency and provide creative, successful solutions


• Knowledge of and experience in CLSI and/or CDISC standards


• Typically requires minimum of 12 years of related work experience with a Bachelor’s degree; or 8 years and a Master’s degree; or equivalent work experience.


• Senior Manager: in addition, 3-6 years of supervisory experience is required and able to effectively lead a team and mentor others.

#LI-REMOTE

Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, Illumina may require proof of COVID vaccination in accordance with local statutory requirements (subject to limited exceptions) beginning November 1, 2021.

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