Associate, Director Biostatistics (NonClinical)

Genomic Health is pioneering the application of genomics to clinical practice in order to dramatically improve the quality of treatment decisions for patients with cancer. The Associate Director/Director of Non-Clinical Biostatistics (NCB) leads a team that collaborates with Biomedical Data Computing, Bioinformatics, Platform Technologies, Process Engineering, Pathology, and Commercial Operations in order to develop and support a wide-ranging spectrum of products that advance Genomic Health as a leLeader in the world of oncogenomics and tumor molecular diagnostics. This position leads a small team of highly technical professionals.

You will be the leader of a team of biostatisticians responsible for contributing to development of new products and technologies in R&D, as well as supporting day-to-day operations in our Clinical Laboratory and other operational laboratory functions, including developing and enhancing Statistical Process Control technologies (SPC) for ongoing process monitoring and troubleshooting.

• You will manage and develop a group of talented scientific and technical staff, including but not limited to, goal setting, performance and compensation review, mentoring and development and staffing plans and hiring decision-making.
• Serves as advisor and mentor to biostatisticians and multi-disciplinary study teams on the strengths, opportunities and limitations of study designs with both innovative state-of-the-art and standard statistical methods, addressing a wide range of problems including, but not limited to, any of the following:
• You'll Development of Next Generation Sequencing, qPCR, IHC or Digital Image based diagnostics
• Optimization, validation, migration, and automation of analytical methods and diagnostic tests
• Deriving specifications for reagent and instrument qualification
• Provide internal statistical review and technology assessment for potential business opportunities, as requested by Senior Management
• Collaborate with the Clinical Laboratory, Biomedical Data Computing, Quality, and IT to automate/industrialize the Clinical Lab operations into an efficient, clear and robust state
• Other responsibilities as assigned
• Advanced degree in either Biostatistics, Statistics or Mathematics
• Normally requires Ph.D and 12+ years of experience, preferably with experience applying statistical methodology in a biotech, diagnostic or life sciences environment
• Solid grounding in statistical theory and familiarity with current developments in statistical methods
• Must have shown expertise with applying appropriate statistical methodologies in the following:
• DOE
• Process development, analytical and methods validation, and troubleshooting
• Complex process optimization
• Statistical process control
• Specification setting
• Skilled at working with large data sets with expertise in large-scale inference, resampling methods, model development and assessment
• Experience with designing and developing biostatistically rigorous studies in support of troubleshooting efforts
• Prior management experience, with the ability to attract, lead, motivate and retain highly educated and talented statisticians and technicians/programmers in a coordinated effort towards a common goal
• Your're first rate interpersonal and communication skills are essential with fellow team members, management and customers who have varied levels of technical or statistical background
• Excellent problem solving skills with an enthusiasm to both lead and contribute to solutions that support our internal customer base
• Demonstrated technical and people leadership skills and a history of success working in cross-functional teams
• Ability to seek, integrate and apply feedback in a professional manner
• Ability to prioritize and deliver results with a high emphasis on quality

Desired

• Proficient in SAS or S+/ R; knowledge of a scripting language and/or SQL desirable
• Familiarity or experience in environments regulated under FDA or ISO
• Familiarity/experience with Big Data and Machine Learning technologies and architectures
• Experience with data visualization and interpretation for audiences not well versed in statistics
• Good teaching/mentoring skills aimed at our internal customer collaborators

CORPORATE OFFICE JOBS:  TRAVEL, PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT:

· Standing or sitting for long periods of time may be necessary 

· Travel Requirements: <10% 

· 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 

· Considerable periods of time may be spent communicating verbally and in various written forms including presentation material and email with other people 

· At times, stress may be experienced 

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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.

Contact: AArroyo@genomichealth.com