Clinical Development and Medical Affairs
GRAIL, Inc., is a discovery-stage life sciences company that is developing differentiated platforms for the early detection of cancer. GRAIL’s research programs combine approaches to ultra-deep sequencing of circulating, cell-free nucleic acids with innovative clinical programs of the scale and quality required to generate strong scientific and clinical evidence of their utility. GRAIL’s software and computational biology efforts are commensurate to the size and complexity of the resulting data sets. We are seeking passionate and talented individuals to join us in realizing our mission, which has the potential to dramatically reduce the global burden of cancer.
The Lead Biostatistician provides statistical expertise and leadership to clinical projects. The Lead Biostatistician partners with key internal and external stakeholders to design, analyze, and interpret clinical studies in support of GRAIL’s product development and pharmaceutical partnerships.
TASKS AND RESPONSIBILITIES
- Provides strategic input for and is a key contributor to GRAIL product development.
- Represents Biostatistics function and collaborates with internal and external thought leaders in the design, analysis, interpretation, and publication of clinical studies.
- Contributes to protocols, statistical analysis plans, study reports, presentations, and publications of clinical studies.
- Works on significant and unique issues that require exercising independent judgment and developing/adapting methodology.
- Stays abreast of industry and academic developments in the Statistical Genomics and Immuo Oncology field and applies to clinical study design and analysis.
- 10+ years of experience in academia or industry. Molecular diagnostics or pharmaceutical industry experience preferred.
- PhD in Biostatistics or equivalent.
- 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 a clinical development program in industry.
- Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA.
- Experience programing in SAS or R.
- Strong team player with demonstrated track record of success in cross-functional team environment.
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.