About the Job

The Biostatistician II will work as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche Pharma and Foundation Medicine, operating as a single unit. 

The Biostatistician II is responsible for providing statistical expertise and managing statistical and other activities for the development and validation of cancer diagnostic and screening tests. The incumbent will design statistically rigorous and efficient assay validation studies, write statistical analysis plans, deliver high quality and timely statistical analyses, co-author study reports, and provide statistical support for regulatory (FDA, PMDA, IVDR, NYS) submissions. The incumbent will explain statistical methods and present analysis results to cross functional teams and regulatory agencies. The incumbent will build and maintain strong collaboration with other teams across the organization. The incumbent has opportunities to participate in translational research and clinical evidence generation studies, collaborate with internal and external partners (e.g. academic or Biopharma collaborators), contribute to scientific publications, and represent FMI in scientific and statistical conferences. 

We are a group of inquisitive biostatisticians, bioinformaticians and scientists within the Research and Development team. We use our quantitative expertise to support the development, validation, and regulatory submission of FMI’s comprehensive genomic tests; to generate clinical evidence for FMI’s innovative assays by designing and executing statistical analysis plans; and to solve scientific problems by building novel statistical and machine learning models. 

Key Responsibilities

• Lead the design and data analysis of analytical and clinical validation studies on novel next generation sequencing (NGS)-based cancer diagnostic tests. 
• Represent Biostatistics in multiple cross-functional projects. 
• Provide key contributions to analytical and clinical studies, including but not limited to protocol development, statistical analysis plans, and data reporting.
• Collaborate with cross-functional teams on study design, planning, data preparation, programming, analysis and presentation of results.
• Contribute to the planning and delivery of key analytical or clinical components of regulatory submissions and respond to review questions.
• Develop innovative and creative statistical and technical solutions to complex problems.
• Maintain statistics quality standards throughout the study process and statistical accuracy in all documents pertaining to the study.
• Ensure statistical work is completed in accordance with established timeframes.
• Maintain availability to the wider FMI business for statistical interpretation and analysis.
• Other duties as assigned. 

Qualifications:

Basic Qualifications:

• Master’s Degree in Statistics, Biostatistics or other quantitative fields plus 2 years of as a biostatistician in biopharmaceutical or diagnostics industry, academia or FDA.
• Strong programming skills in R, OR
• PhD in Statistics, Biostatistics or other quantitative fields.
• Strong programming skills in R

Preferred Qualifications:

• Doctor of Philosophy in Statistics, Biostatistics or other quantitative fields with 1+ years of experience as a biostatistician in biopharmaceutical or diagnostics industry, academia or FDA.
• Experience in analytical validation of medical devices, cancer screening tests, time-to-event data analysis and longitudinal data analysis.
• Extensive scientific understanding of cancer genetics and genomics.
• Knowledge with NGS and experience of genomic data analysis.
• High level of detail orientation with a focus on quality.
• Leadership skills including proactive strategy setting, priority evaluations, conflict resolution, and effective partnerships.
• Proficiency in R. Experience with Python is desired.
• Excellent communication, presentations and writing skills, and the ability to explain complex technical details in clear language.
• Demonstrated ability to meet project deadlines.
• Demonstrated record of successful independent work and contributions to team projects.
• Ability to work well under pressure while maintaining a professional demeanor.

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