Senior Director, Biostatistics # 2533

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. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.

The Senior Director of Biostatistics manages a group of biostatisticians to provide statistical expertise and leadership to pre-analytical and analytical assay studies across GRAIL portfolio. The Senior Director of Biostatistics partners with key internal stakeholders to design, analyze, and interpret pre-analytical and analytical studies in support of GRAIL’s product development.
You will:

• Provides strategic input for and is a key contributor to GRAIL product development.
• Manages and provides guidance to a group of assay biostatisticians
• Provides statistical leadership in support of pre-analytical and analytical studies in the study design, analysis, study reports, presentations, publications and regulatory filings.
• Has the ability to influence internal collaborators on issues of study design, statistical methods, interpretation of results, etc.
• Works on significant and unique issues that require exercising independent judgment and developing/adapting methodology.
• Demonstrates industry leading knowledge in the Statistical Genomics, CLSI guidelines, FDA regulations, and applies those to pre-analytical and analytical study design and analysis.
• Provides statistical leadership to assay development and process monitoring, reagent specification setting, troubleshooting and data QC activities.
• Create formal networks with key decision makers and serve as external spokesperson for the organization 

Your qualifications and experience will include:

• 15+ years of experience in academia or industry with at least 5 years of managerial experience.
• 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 in managing a group and leading the statistical portion of a NGS assay development program in industry.
• Experience programming in R (preferred), Python or SAS.
• Strong team player with demonstrated track record of success in cross-functional team environment.
• Prior FDA filing experience strongly preferred.

GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Following extensive monitoring, consideration of business implications, and advice from internal and external experts, GRAIL US has made the decision to require that all U.S. employees be “Fully Vaccinated” with the COVID-19 vaccine. “Fully Vaccinated” is defined as two weeks after both doses of a two-dose vaccine (e.g. Pfizer or Moderna) or two weeks since a single-dose vaccine (e.g. Johnson & Johnson) has been administered. Absent a qualifying exemption, all GRAIL US employees are to comply with this requirement, including providing documentation of such vaccination status, as a condition of employment. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation for consideration by GRAIL.