Biostatistical Director / Associate Biostatistical Director / Biostatistical Manager
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.
This position provides statistical expertise and leadership to clinical development and phase III or IV clinical trials. This position will partner with key internal and external stakeholders to design, analyze, and interpret phase III / IV clinical studies in support of GRAIL's product development, commercialization, and payer's reimbursement.
• Act as the lead biostatistician on a newly announced landmark clinical trial involving 140,000 participants with the UK National Health Service (NHS)
• Provide strategic input for and be a key contributor to GRAIL product development, post-launch activities, and payer's reimbursement.
• Represent the Biostatistics function and collaborate with internal and external thought leaders in the design, analysis, interpretation, and publication of phase III / IV clinical studies.
• Co-author protocols, statistical analysis plans, study reports, presentations, and publications of clinical studies.
• Contribute to the development of innovative analysis methodologies, including cutting- edge machine learning algorithms
• Work on significant and unique issues that require exercising independent judgment and developing/adapting methodology.
• Stay abreast of industry and academic developments in the Statistical Genomics and Immuno-oncology field and apply to clinical study design and analysis.
Your Background Should Include:
• Ph.D. in Biostatistics or equivalent with 5+ years of experience (or MS with 7+ years) in academia or industry. Molecular diagnostics or pharmaceutical industry experience preferred.
• Ph.D. with 10+ years of experience will be considered at the Associate Biostatistical Director level.
• Ph.D. with 13+ years of experience will be considered at the Biostatistical Director level.
• Strong knowledge of theoretical and applied statistics
• Proven track record of success in leading large-scale clinical trials as biostatistician
• 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 the industry.
• Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA.
• Experience programming in R or SAS.
• Strong team player with a demonstrated track record of success in the cross-functional team environment.
• Experience with machine learning techniques is a plus
• Experience with genomic data analysis is a plus
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.