Genomic Health is seeking an exceptional individual with strong statistical, interpersonal and organizational skills to provide and oversee biostatistical support for marketed genomic assays that enable better treatment decisions for patients with breast and colon cancer. The Associate Director, Biostatistics - Medical Affairs participates in the development and implementation of U.S. and International Medical Affairs strategies; the design, analysis and publication of results from Medical Affairs studies; international regulatory and reimbursement submissions; and planning and development of publications, product messaging, marketing materials, and education and training materials.
The Associate Director, Biostatistics - Medical Affairs collaborates with other members on the Genomic Health team as well as clinical investigators and statisticians outside of the Company, and engages with key opinion leaders. The Associate Director, Biostatistics - Medical Affairs reports to the Vice President, Clinical Biostatistics and maintains close and frequent coordination with the Colon and Breast Lead Program Biostatisticians. This position does not support development of new products.
- Coordination and oversight of statistical support for all Breast and Colon Medical Affairs studies, including investigator-sponsored studies. Identification of resource needs, and coordination of in-house biostatistical resources as needed. Management and oversight of outsourcing of clinical biostatistics activities when internal resources are insufficient.
- Design, analysis and publication/presentation support for Medical Affairs studies, including decision impact studies, patient registries and investigator-sponsored trials. Review and evaluation of investigator study proposals. Supports analyses of commercial data and associated publications. Provides input and review for health economics studies. Supports additional activities related to reimbursement, including international regulatory and reimbursement submissions and responses.
- Member of Domestic and international Medical Affairs Study Teams
- Member of Joint Breast and Colon Medical/Marketing Team
- Member of Domestic and International Commercial Teams
- Responsible for statistical review of marketing, sales, education and training materials pertaining to clinical data and product claims. Responsible for statistical review of Medical Affairs and Commercial publications.
- Maintain close collaboration with product development biostatisticians and market access. Interfaces with International Market Access/Reimbursement Director.
- Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria fit for the specific purpose. Ensures budgets, schedules and performance requirements are met.
- May manage the activities of lower level personnel.
- Other responsibilities as assigned.
- Ph.D. in Biostatistics/Statistics or comparable demonstrated technical ability
- Minimum of 8 years relevant experience in academia or industry, including at least 4 years relevant experience in industry
- Sound knowledge of theoretical and applied statistics, including survival analysis and epidemiological methods
- Extensive experience in supporting congress presentations and publishing in peer-reviewed clinical journals
- Experience in coordinating statistical support for a multifaceted project, including managing outsourced statistical services
- Professional manner with outstanding written and oral communication skills; ability to engage effectively throughout all levels of the organization and externally with key opinion leaders
- Strong statistical analysis skills in SAS. Experience in R or S-plus desirable.
- Able to work effectively in a multi-disciplinary team including medical, marketing, sales, and reimbursement functions.
- Demonstrated ability to interact with and effectively influence external collaborators on study design, analysis methods, and interpretation of study results, in consultation with Medical Affairs, senior management and the program biostatistician.
- Detail-oriented with an ability to see the big picture and think strategically.
- Able to integrate and apply feedback in a professional manner
- Able to prioritize and drive to results with a high emphasis on quality
- Strong managerial and leadership skills and experience desirable, including recruiting, mentoring, and developing professional employees.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT :
- Moderate travel (≤20%) required to professional congresses and collaborator meetings
- Standing or sitting for long periods of time may be necessary
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