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Sr Staff Biostatistician

Yoh Staffing Solutions Foster City, CA

  • Posted: over a month ago
  • Contractor
Job Description

Sr Staff Biostatistician for a contract opportunity with Yoh’s client located in Foster City, Ca.

The Big Picture – Top Skills You Should Possess:

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

You’ll Be Doing:

  • Provide statistical expertise for clinical validation studies to achieve regulatory approval of IVD and CDx assays in the US and internationally (including FDA PMA 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.
  • Consult on complex study design and proposal development, planning, and strategy for companion diagnostic clinical validation.
  • Provide statistical designs for clinical studies based on regulatory guidance or standards and input from clinical and medical subject matter experts.
  • 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 and represent Illumina in discussions with the FDA as needed.
  • 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.
  • Master's degree in Biostatistics, Statistics, or related field preferred.
  • Experience in planning, analyzing, and reporting of clinical studies in the diagnostic industry is required.
  • Experience with companion diagnostics is required, sound knowledge of pharmaceutical clinical trials is desirable.
  • Proficiency in at least one statistical analysis software package (e.g., SAS, R).
  • Excellent verbal and written communication skills for both technical and non-technical audiences.
  • Experienced in and full understanding of the following areas of statistics: clinical studies for IVDs and CDx; sample size/power estimation based on theoretical and simulation/resampling methods; randomized controlled studies; observational studies; missing data imputation; and survival analysis.
  • Knowledge of and experience in applying related regulatory guidance/standards.
  • Minimum of 8 years and a Master’s degree, or a PhD with 5 years’ experience; or equivalent work experience.

 

 

 

What’s In It For You?                    

We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

Medical, Dental & Vision Benefits

401K Retirement Saving Plan

Life & Disability Insurance

Direct Deposit & weekly epayroll

Employee Discount Program’s

Referral Bonus Program’s

 

Opportunity is Calling, Apply Now!

Recruiter: Mary Nguyen at mary.nguyen@yoh.com

 

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Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.
Company Description
Investment Management Company

Yoh Staffing Solutions

Investment Management Company

Yoh Staffing Solutions's Logo

Address

Foster City, CA
USA

Industry

Technology

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