Biostatistical Manager #4010

About the position

The Biostatistical Manager will operate as a strategic thought leader in the Biostatistics Department to provide strategic input to GRAIL product pre-launch and post-launch activities including RWE generation. This role involves contributing 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. The manager will collaborate with cross-functional teams to lead and support reporting of clinical studies and RWE studies for regulatory submissions, health technology assessments (HTAs), and publications. Additionally, the manager will assist in various Clinical Development and Medical Affairs activities, lead future studies involving claims databases and registries, and stay updated on industry developments in Statistical Genomics and real-world evidence generation.

Responsibilities

• Contribute to the preparation of study protocols and development of statistical analysis plans.
• Implement innovative statistical methods and write programs to execute analyses.
• Assist with the interpretation and dissemination of findings.
• Lead and support reporting of clinical studies and RWE studies for regulatory submissions and publications.
• Assist in developing abstracts and managing ad-hoc requests for Clinical Development and Medical Affairs activities.
• Lead future studies involving claims databases and registries.
• Stay abreast of industry developments in Statistical Genomics and real-world evidence generation.
• Present statistical methodologies and issues in departmental and company-wide meetings.

Requirements

• PhD in Biostatistics or related field with 5+ years of experience, or MS with 8+ years of experience in academia or industry.
• At least 3 years of experience in the fields of RWE and Epidemiology.
• Strong knowledge of theoretical and applied statistics, particularly in epidemiology, health economics, and outcomes research (HEOR).
• Experience with statistical methods such as propensity score matching, longitudinal data analysis, and survival analysis.
• Outstanding verbal, writing, and presentation skills.
• Demonstrated success leading statistical evaluations in the diagnostic/IVD or pharmaceutical industry.
• Knowledge of applicable regulatory rules and guidelines (ICH, GCP, HIPAA, NICE, RWE guidelines).
• Experience programming in R or related programming environments (e.g., SAS).

Nice-to-haves

• Molecular diagnostics or pharmaceutical industry experience.
• Familiarity with traditional performance metrics of clinical diagnostic tools.

Benefits

• Flexible time-off
• 401k with company match
• Medical, dental, and vision plans
• Mindfulness offerings
• Annual bonus plan tied to performance
• Long-term incentive plan to align company and colleague success.