The Director of Non-Clinical Biostatistics (NCB) works with the NCB staff, internal Research and Development (R&D) customers, and the clinical laboratory operations staff to plan, design, and conduct studies aimed at overseeing and monitoring day-to-day operations in our Commercial /Clinical Lab. This individual will also ensure that the NCB group provides complete and transparent support for the laboratory team and the QC group by developing, enhancing, validating and monitoring the processes for the performance of complex genomic assays in our Commercial Laboratories.
The ideal candidate will have a proven track record of both innovative and pragmatic biostatistics/industrial statistics and will deliver an applied, high throughput, industrial Statistical Process Control system for all lab operations. He/she will be a proven team player with leadership skills and management experience. This position will directly lead a team within the NCB organization.
* Leadership of a team of biostatisticians responsible for supporting all day-to-day operations efforts in our Clinical Laboratories. These efforts will include developing and enhancing Statistical Process Control technologies (SPC), for both monitoring and troubleshooting the day-to-day operations activities in our clinical laboratories
* As part of these efforts, this role will build and manage a team to develop an internal Center of Excellence for quality operations. These efforts will include, but not be limited to, the development, validation, and operationalization of near-real time statistically rigorous monitoring technologies, establishing calibration settings, and setting appropriate specifications for internal quality checks.
* Manage a group of talented scientific and technical staff, including but not limited to, goal setting, performance and compensation review, mentoring and development and, in conjunction with the Sr. Director of Non-Clinical Biostatistics, staffing plans and hiring decision-making
* Collaboration with the Clinical Laboratory, Biomedical Data Computing, QA, and IT Data Services to automate/industrialize these efforts into an efficient, transparent and industrial state
*Active partnering with Biomedical Data Computing and IT to ensure effective use of Genomic Health’s substantial compute resources
*Work with senior management to support the creation and execution of research, technology and product development strategies that will establish Genomic Health, Inc. as a powerful force in the world of oncogenomics and tumor molecular diagnostics
* Other duties as assigned
* Ph.D. in Biostatistics or Industrial Statistics, with at least 12 years of experience in a related operational environment, including process development, monitoring, and troubleshooting
* Must have proven expertise with applying appropriate statistical methodologies to the following:
- Process development, validation, and troubleshooting
- Complex process optimization
- Complex data monitoring
- Statistical process control
- Variance component estimation
- Specification setting
* Experience with designing and developing biostatistically rigorous studies in support of troubleshooting efforts
* Minimum of 7 years management experience, with the ability to attract, lead, motivate and retain highly educated and talented statisticians and technicians/programmers in a cooperative effort towards a common goal
* Demonstrated desire to mentor and develop others
* 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 integrate and apply feedback in a professional manner
* Ability to prioritize and drive results with a high emphasis on quality
* Demonstrated excellence as a team player
* Strong communicator with an ability to maintain open communication with internal customer/colleagues, management and external customers or collaborators as needed.
* Ability to communicate effectively both in writing and orally with both technical and non-technical end-users
* Experience managing a group of with moderate size (5-10 employees)
* Proficiency in SAS and/or knowledge of S+ and R
* Good presentation skills and proficiency
* Experience with data visualization and interpretation for audiences not well versed in statistics
* Good teaching/mentoring skills aimed at our internal customer collaborators
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:
* Travel Requirements: <10% travel – for technology assessment, conference participation or professional development.
* Standing or sitting for long periods of time may be necessary