Senior Director Biostatistics (Clinical)

Organization
Genomic Health
Job Location
Redwood City, CA 94063
Job Description

The Sr. Director, Biostatistics leads the Clinical Biostatistics function, consisting of a team of skilled technical professionals, which participates in the design, analysis and reporting of studies of genomic markers from patients in controlled clinical trials and observational studies in oncology and urology. These studies span multiple phases of clinical biomarker discovery, development and post-marketing support, including clinical feasibility, assay development, clinical validation, and clinical utility, as well as Medical Affairs studies of our marketed genomic assays. This is a senior management role that requires effective staff management, mentoring, and development. The Sr. Director, Biostatistics is an influential leader within the company; champions appropriate statistical approaches for the design and analysis of clinical studies and interpretation of data; has external influence on the field of biomarker development; and participates in business development activities. The Sr. Director, Biostatistics reports to the Vice President, Biostatistics & Data Management.

 

The ideal candidate will have a proven track record of both innovative and pragmatic biostatistics, collaborative publication in clinical oncology journals, as well as demonstrated motivation for and excellence in people management and leadership.

  • Ensures that clinical biostatisticians meet program needs according to timelines, with appropriate quality and budget control, based on company priorities
  • Accountable for technical review of functional deliverables, including clinical study protocols, analysis plans, final study reports, and associated abstracts, posters and publications
  • Responsible for maintaining a broad understanding of relevant external global trends, anticipating emerging issues relevant to the clinical biostatistics function, identifying strategic needs in technical knowledge, fostering innovation, and aligning the strategic direction and execution plan for the function with business needs
  • Participates in due-diligence assessments and integration activities for business development opportunities
  • Creates networks with external clinical and statistical collaborators and influences internal and external decisions to ensure quality of study designs and analyses, appropriateness of inferences and conclusions, and alignment with GHI strategic interests
  • Direct management responsibilities, including but not limited to, goal setting, performance and compensation review, mentoring and development
  • Accountable for assessing functional headcount needs, allocating resources, and making recruiting and hiring decisions
  • Accountable for identifying functional process needs, developing operating procedures, and ensuring technical training and regulatory compliance of staff
  • Engages cross-functionally to optimize collaboration, resolve cross-functional operational challenges, and leverage resources efficiently
  • Invests in the Biostatistics & Data Management team culture and environment to build high morale and commitment to company, team and individual goals and objectives
  • Other responsibilities as assigned

 

REQUIRED

  • Ph.D. in Biostatistics/Statistics or comparable demonstrated technical ability
  • 20+ years of relevant experience, including experience in industry and managing others
  • Sound knowledge of theoretical and applied statistics, including survival analysis methods and epidemiologic methods
  • Demonstrated leadership abilities and enthusiasm to hire, mentor, develop, and inspire a group of highly effective, qualified individuals who implement the development and commercialization strategy for all Company products
  • Experience with design and analysis of clinical trials
  • Record of peer-reviewed publication of oncology clinical trials and/or cancer epidemiologic studies
  • Effective decision-maker who considers cross-functional and global perspectives, and applies knowledge, detailed analysis, seasoned experience, and sound judgment in making decisions that may involve limited or ambiguous information
  • Experience with FDA regulation
  • Strong verbal, written, and presentation skills
  • Demonstrated ability and experience in leading collaborative efforts to obtain and analyze complex data.
  • Effective programming skills in SAS
  • Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed
  • Actively seeks, integrates and applies feedback in a professional manner
  • Able to prioritize and drive to results with a high emphasis on quality

 

DESIRED

  • Experience in the analysis of genomic studies
  • Experience with PMA and 510-K submissions
  • Knowledge of R programming

TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:

 

  • Travel Requirements: 10% Travel, valid passport and driver's license required
  • Standing or sitting for long periods of time may be necessary

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