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