GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.
The Director / Associate Director of Medical Affairs Biostatistics provides statistical oversight and leadership to post-market clinical projects. This position will partner with key internal/external stakeholders and oversee all statistical activities in designing, analyzing, interpreting, and publishing post-market clinical studies in support of GRAIL’s product development, commercialization, post-launch activities, and payer reimbursement.
- Operate as a strategic thought leader in Biostatistics to provide strategic input to GRAIL product post-launch activities.
- Build the Medical Affairs Biostatistics group and provide all directional and technical oversight.
- Develop group policies and oversee the implementation of these policies
- Represent the Biostatistics function and collaborate with internal/external thought leaders in the design, analysis, interpretation, and publication of post-market clinical studies.
- Provide statistical leadership to the development of protocols, statistical analysis plans, study reports, presentations, and publications of post-market clinical studies.
- Work on significant and abstract issues that require independent judgment and developing creative resolution through assessment of intangible variables
- Stay abreast of industry and academic developments in the Statistical Genomics and real-world evidence generation and apply to clinical study design and analysis.
Your Background Will Include:
- PhD in Biostatistics or equivalent with 15+ years of experience (or MS with 17+ years) in academia or industry will be considered at the Director level. Molecular diagnostics or pharmaceutical industry experience preferred.
- PhD with 10 to 14 years of experience will be considered at the Associate Director level.
- Demonstrated success in managing a group of PhD level biostatisticians is strongly preferred
- Strong knowledge of theoretical and applied statistics
- Outstanding verbal, writing, and presentation skills with a strong ability to influence and communicate effectively throughout all levels of the organization and externally.
- Demonstrated success leading the statistical portion of post-launch product evaluation in industry.
- Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA, Real-world Evidence guideline.
- Experience programming in R or SAS.
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.
Read Full Job Description