Sr Staff Biostatistician at Illumina, Inc. in San Diego, California

Job Description:

Position Summary

Provide statistical support for product development, analytical and clinical validation studies to achieve regulatory approval of in vitro diagnostic and companion diagnostic assays in the US and internationally (including FDA PMA, 510(k), and equivalent EU approval).  The role includes:

• design statistical aspects of studies, write statistical analysis plans, analyze data, write statistical reports and statistical content for regulatory submissions,


• collaborate with cross-functional teams on study designs, strategies, and analysis approaches consistent with best statistical practices and regulatory requirements.

Responsibilities

• Consult on complex study design and proposal development, planning, and strategy for companion diagnostic product development and validation.


• Provide statistical designs for clinical or analytical studies based on regulatory guidance or CLSI (Clinical and Laboratory Standards Institute) standards.


• Write, review and edit statistical analysis plans and study 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 teams outside biostatistics.


• Create all relevant documentation pertaining to statistical design and analysis at a level consistent with auditable standards in the IVD industry.

Requirements

• Master's degree in Biostatistics, Statistics or related field preferred.


• Experience in planning, analyzing, and reporting of clinical studies in the diagnostic industry preferred.


• Experience with companion diagnostics is desirable. 


• 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: clinical or analytical studies for in vitro diagnostics (IVDs); companion diagnostics; ROC analysis; linear models including analysis of variance and regression analysis; sample size/power estimation; Design of Experiments (DOE), clinical trials; randomized controlled studies; observational studies; missing data imputation; and survival analysis.


• Knowledge of and experience in applying CLSI and other related regulatory guidance/standards.


• Able to travel domestically or internationally, as required up to 10%.


• Minimum of 12 years of related work experience with a Bachelor’s degree; or 8 years and a Master’s degree, or a PhD with 5 years experience; or equivalent work experience.

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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