Biostatistician, Companion Diagnostics

Organization
Agilent Technologies, Inc. US
Job Location
Carpinteria, CA,
Job Description

We are currently seeking an experienced Biostatistician with medical device background for our Dako North America office in Carpinteria, CA to work within the field of Companion Diagnostics.

Job Summary
Work in a dynamic environment in the field of Oncology!

Responsibilities/Deliverables:

-Prepares statistical analysis plans and writes detailed specifications for analysis methods.
-Interprets analyses and writes statistical sections of study protocols and reports.
-Supports teams in the planning, design, conduct, and reporting of studies, as well as in regulatory submissions, to meet project objectives, including internal/external validation, and clinical studies.
-Collaborates with pharmaceutical partners in support of clinical development projects and presentations/publications.
-Communicates with the FDA regarding statistical analysis issues. Provides technical and strategic support in resolving issues.

Required Skills:

-Strong knowledge of statistical (theoretical) principles and applied statistics.
-Experience with statistical software such as R, S-Plus, and SAS.
-Good understanding of molecular biology, cancer, immunology, genetics or genomics in addition to standard molecular assays and technologies (including IHC and FISH).
-Ability to create study specifications and provide support in the review of data management documentation.
-Stays up-to-date on new developments in statistics, molecular technology, drug development and regulatory guidance through literature review, industry workshops, etc.

Requirements:
Qualifications:

-Requires a master's degree/PhD in biostatistics or related area and 2-5 years of experience in the medical device field.

Other Qualifications

-Ability to provide mentorship and promote teamwork in a multi-disciplinary team setting.
-Good organizational skills with the ability to adapt and adjust to changing priorities.
-A certain degree of creativity and latitude is required.
-Relies on experience and judgment to plan and accomplish goals.
-Excellent written and verbal communications skills.
-Positive attitude and the ability to work well with others.

We offer:

A challenging job, working with one of the most rapidly growing areas in the biopharmaceutical industry. You will become part of company that works according to these values:
- We move cancer diagnostics forward
- We care about the needs of our customers and cancer patients and strive to ensure people are treated consistently, fairly and with respect
- We deliver effective diagnostic solutions valued by our customers
- We are passionate with quality in the solutions we provide to our customers, in the talented people we attract and develop, and in the processes we work by

Geo Location: Carpinteria, CA

Agilent is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to disability, protected veteran status or any other protected categories under all applicable laws.

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