Principal Biostatistician (Clinical)

Genomic Health is seeking an extraordinary individual with strong statistical, data analysis, interpersonal, and organizational skills, to participate in the development and validation of genomic biomarker assays that help cancer patients and their physicians make better treatment decisions. You will collaborate directly with internal and external leaders with vision in the design, analysis, reporting, and publication of studies associating genomic data with clinical outcomes in patients from controlled clinical trials and observational studies in oncology. You'll have experience analyzing high dimensional data, preferably genomic data, relevant work experience, and an in-depth understanding of survival analysis methods.

Responsibilities

• You will perform statistical activities in support of development, validation, and post-marketing studies, including protocol and statistical analysis plan development, data analysis, preparation of final study reports, and contribution to external presentations and publications
• Represents the statistics function in clinical development teams, medical affairs, and marketing/commercial activities
• Provides strategic input to the project teams and is a major contributor to the design of clinical studies
• You'll work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises discernment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
• Interacts with external clinical and statistical collaborators
• No direct management responsibilities but may mentor less senior personnel
• Other responsibilities as assigned

Qualifications:

• Ph.D. in Biostatistics/Statistics
• A minimum of 8 years of relevant work experience
• Sound knowledge of theoretical and applied statistics
• Experience analyzing time to event data from clinical trials and/or observational studies
• Strong statistical programming and analysis skills in SAS
• Experience in publishing the results of clinical, epidemiologic or genomic studies
• Excellent oral, written, and presentation skills
• Professional manner with the ability to communicate effectively throughout all levels of the organization
• Able to work in a multi-disciplinary team including scientists, pathologists, and oncologists
• Demonstrated ability to interact with and influence internal and external collaborators on study design, analysis methods, and interpretation of study results
• Able to prioritize and work towards results with a strong emphasis on quality
• Able to integrate and apply feedback in a professional manner

Desired

• Experience in statistical analysis in oncology and clinical diagnostics
• Familiarity with genomic assay development
• Experience working in the FDA regulated industry
• Experience using R

Travel, physical demands and work environment:

• Travel Requirements: 10%
• Standing or sitting, Use of computer, and or telephone for long periods of time may be necessary
• Considerable periods of time may be spent concentrating and or analyzing data, communicating verbally and in various written forms including presentation material and email with other people
• At times, stress may be experienced

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

AArroyo@genomichealth.com