Staff Biostatistician, Medical Affairs/RWE #2679

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 Staff Biostatistician of Medical Affairs Biostatistics will provide statistical support and guidance on premarket approval registry/observational studies, post-market clinical and Real World Evidence (RWE), HEOR, and epidemiological studies. This position will partner with key internal and external stakeholders and support all statistical and methodological 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.  

RESPONSIBILITIES

• Operating as a strategic thought leader in the Biostatistics Department to provide strategic input to GRAIL product premarket approval registry/prospective studies and post-launch activities, and RWE generation
• Contributing to the preparation of study protocols, developing statistical analysis plans, implementing innovative statistical methods, writing programs to execute analyses, and assisting with the interpretation and dissemination of findings
• In collaboration with cross-functional teams, lead/support reporting of RWE study results for regulatory submissions, health technology assessments (HTAs), and publications
• Assisting a variety of Medical Affairs activities in developing abstracts, publications, and managing ad-hoc requests in collaboration with members from a cross-functional team 
• Leading and supporting future RWE clinical retrospective studies that involve claims databases (e.g., MarketScan, Pharmetrics, etc), EMR/EHR (e.g., Flatiron’s oncology EHR databases), and registries as a seasoned biostatistician
• Staying abreast of industry and academic developments in the Statistical Genomics and real-world evidence generation and apply to clinical study design and analysis
• Presenting some of the state-of-the-art statistical methodologies and issues via various departmental and company-wide meetings

PREFERRED BACKGROUND

• PhD in Biostatistics or equivalent with 4-5 years of experience (or MS with 6+ years) in academia or industry 
• Familiarity with traditional performance metrics of clinical diagnostic tools
• At least 3 years of experience in the fields of RWE and Epidemiology as a biostatistician 
• Strong knowledge of theoretical and applied statistics, particularly in the fields of epidemiology, health economics and outcomes research (HEOR), and RWE (e.g., propensity score matching/weighting/subclassification, longitudinal data analysis, difference-in-differences estimation, synthetic/external control arms, indirect treatment comparisons, network meta analysis, count data regressions, parametric/non-parametric survival analysis (e.g., competing risks models, multi-state models, frailty random effects models, etc)
• 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 the diagnostic/IVD or pharmaceutical industry is a plus
• Knowledge of applicable regulatory rules and guidelines, not limited to ICH, GCP, HIPAA, NICE, and other RWE guidelines
• Experience programming in R or related programming environment (e.g. SAS)

The estimated, full-time, annual base pay scale for this position is $154,000 - $204,000.  Actual base pay will consider skills, experience, and location. 

Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.

In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.

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. GRAIL maintains a drug-free workplace.


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.