Biostatistical Manager/Senior Biostatistician - Medical Affairs

Employer
GRAIL, Inc.
Location
Menlo Park, CA, United States
Posted
May 19, 2021
Ref
401202495
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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.

We are looking for a Biostatistical Manager /Senior Biostatistician of Medical Affairs Biostatistics to provide statistical support and guidance on post-market clinical and Real World Evidence (RWE) studies! This individual will be working in collaboration with key internal and external stakeholders to 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.

You Will:

• Operate as a strategic thought leader in the Biostatistics Department to provide strategic input to GRAIL product post-launch activities and RWE generation
• Contribute to the preparation of study protocols, development of statistical analysis plans, implementation of innovative statistical methods, writing programs to execute analyses, and assisting with the interpretation and dissemination of findings
• In collaboration with cross-functional teams, lead and support reporting of RWE study results for regulatory submissions, health technology assessments (HTAs), and publications
• Assist a variety of Medical Affairs activities in developing abstracts, publications, and managing ad-hoc requests in collaboration with the Associate Director, Biostatistics Medical Affairs
• Lead and support 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
• Stay abreast of industry and academic developments in the Statistical Genomics and real-world evidence generation and apply to clinical study design and analysis
• Present some of the state-of-the-art statistical methodologies and issues via various departmental and company-wide meetings

Your Background Will Include

• PhD in Biostatistics or related field with 5+ years (or MS with 8+ years) in academia or industry experience including at least 3 years of experience in the fields of RWE and Epidemiology to be considered at the Biostatistical Manager level.
• PhD with 2 - 5 years of experience (or MS with 5+ years) including at least 1-2 years of experience in the fields of RWE and Epidemiology to be considered at the Senior Biostatistician level
• Molecular diagnostics or pharmaceutical industry experience preferred
• Familiarity with traditional performance metrics of clinical diagnostic tools
• 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, longitudinal data analysis, difference-in-differences estimation, synthetic/historical 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)

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.

GRAIL, Inc. and its affiliates and subsidiaries ("GRAIL") does not accept any liability for fees for resumes from recruiters or employment agencies ("Agency"), without a binding, written recruitment agreement between GRAIL and Agency describing the services and specific job openings ("Agreement"). GRAIL may consider any candidate for whom an Agency has submitted an unsolicited resume and explicitly reserves the right to hire those candidate(s) without any financial obligation to the Agency, unless an Agreement is in place. Any email or verbal contacts with any person within GRAIL is inadequate to create a binding agreement. Agencies without an Agreement are requested not to contact any hiring managers of GRAIL with recruiting inquiries or resumes. Agencies interested in partnering with GRAIL may contact GRAIL's HR Department through our Customer Service team .