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 SummaryThe successful candidate will be the subject matter expert in statistics and provide thought leadership in clinical study design, analysis, and reporting, for registrational studies for in vitro diagnostic (IVD) and companion diagnostic (CDx) assays in the US and internationally (including FDA PMA, 510(k), and equivalent EU approval). This is an individual contributor role and will not have direct reports.ResponsibilitiesDevelop statistical designs and analysis methodologies for clinical studies, author statistical analysis plans, analyzed data, and write statistical reports.Utilize appropriate statistical methodologies and techniques to analyze data and summarize data analysis results orally and in written form.Support responses to statistical queries from regulatory bodies.Participate in project team meetings.Lead internal biostatistics meetings and biostatistics-related meetings with Illumina stakeholder teams.Create all relevant documentation pertaining to statistical design and analysis at a level consistent with auditable standards in the IVD industry.Develop innovative statistical methods and influence industry standards.Develop processes, standards, and trainings to improve departmental efficiency.RequirementsMinimum of a Master's degree in Biostatistics, Statistics or related field.Experience in planning, analyzing, and reporting of clinical studies in the diagnostic industry preferred.Experience with companion diagnostics is desirable. Knowledge of and experience in applying CLSI and other related regulatory guidance/standards.Proficiency in at least one statistical analysis software package (e.g. SAS, JMP scripting, R).Excellent verbal and written communication skills for both technical and non-technical audiences.Able to prioritize work and complete deliverables to timelines with minimal or no supervision.Experienced in and full understanding of at least one area of statistics: analytical or clinical studies for in vitro diagnostics (IVDs); companion diagnostics; linear models including analysis of variance and regression analysis; sample size/power estimation; Design of Experiments (DOE), randomized controlled studies; observational studies; missing data imputation.Knowledge of and experience in applying CLSI or other related regulatory guidance/standards.Able to travel domestically or internationally, as required up to 10%.Experience/Education: Sr. Staff level: 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. ($149,600 - $224, 400 USD)Staff level: typically requires minimum of 8 years of related work experience with a Bachelor’s degree; or 6 years and a Master’s degree; or equivalent work experience. ($124,300 - $186,500 USD)All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.#LI-REMOTEThe estimated base salary range for the Staff or Sr. Staff Biostatistician - Clinical Trials (Remote) role based in the United States of America is: $124,300 - $186,500. Should the level or location of the role change during the hiring process, the applicable salary 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
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