Sr. Biostatistician

Illumina

San Diego, California

Date Posted November 02, 2021
Industry Private Sector BioStat Jobs
Specialty Not Specified
Job Status Full-time
Salary Not Specified

Description:

Job details

Job Type
Full-time

Full Job Description

Position Summary
Illumina seeks an experienced statistician to 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
  • 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.
  • Create all relevant documentation pertaining to statistical design and analysis at a level consistent with auditable standards in the IVD industry.
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Requirements:
  • Master's degree in Biostatistics, Statistics or related field preferred.
  • Minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree, or a PhD without experience; or equivalent work experience.
  • 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 is preferred.
  • Proficiency in at least one statistical analysis software package (e.g. SAS, JMP scripting, R).
  • Good verbal and written communication skills for both technical and non-technical audiences.
  • Able to prioritize work and complete deliverables to timelines with minimal 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.
All listed requirements are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
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.