The Lead Medical Affairs Biostatistician leads Biostatistics support of Medical Affairs. This individual 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; domestic and international reimbursement submissions; planning and development of publications, product messaging, marketing materials, and education and training materials; and interfaces with the head of the Clinical Biostatistics function in ensuring effective execution of Medical Affairs studies. This individual collaborates with other members in Genomic Health cross-functional teams as well as clinical investigators and statisticians outside of the Company, and engages with key opinion leaders. This position reports to the Senior Director, Clinical Biostatistics and maintains close and frequent coordination with Program Biostatisticians for each of the commercialized products. This position does not support development of new products.
- Coordination and oversight of statistical representation for all Medical Affairs studies supported by the Clinical Biostatistics function and direct participation as a team member, including review and analysis of proposals, study design, analysis, and reporting.
- Supports analysis of commercial data and associated publications.
- Critically reviews Genomic Health and competitor abstracts, posters and publications.
- Provides statistical review of marketing, sales, and education and training materials pertaining to clinical data and product claims.
- Member of the Promotional Review Committee representing Translational Sciences accountabilities.
- Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles, and may impact our current products.
- Creates networks with external clinical and statistical collaborators and influences decisions to ensure quality of study designs and analyses, appropriateness of inferences and conclusions, and alignment with Genomic Health strategic interests.
- May oversee and manage the activities of lower level personnel; primary role is an individual contributor.
- May direct the work of and review the deliverables of consultants.
- Master's or Ph.D. in Biostatistics/Statistics or comparable field
- Minimum of 15 years relevant experience
- Sound knowledge of applied statistics, including survival analysis and epidemiological methods
- Experience working on post-marketing and reimbursement studies
- 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 demeanor 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.
- Able to work and influence 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
- Demonstrated ability to work effectively in a matrix organizational environment
- Able to integrate and apply feedback in a professional manner
- Able to prioritize and drive to results with a high emphasis on quality.
- Demonstrated ability and desire to lead high performing teams with sound analysis and judgment
- Innovative and forward thinking; reacts positively to changing conditions, shifting priorities and mid-course corrections.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT:
- Moderate travel (≤20%) required to attend professional congresses and collaborator meetings
- Standing or sitting for long periods of time may be necessary