Senior Biostatistician

Invivoscribe is an industry pioneer in oncology diagnostics, dedicated to improving the standard of global healthcare for over 25 years. Headquartered in sunny San Diego, California with locations across the world, we offer a comprehensive portfolio of products and services.  We work with key collaborators to develop molecular assays, reagents, controls and bioinformatics tools under ISO 13485 design control that are used in over 160 countries. Our global network of laboratories offer next generation molecular and flow cytometry panels to support our drug development entity and accelerate clinical trials. Our harmonized clinical laboratories offer a menu focused on clinically significant biomarkers which support therapeutic decisions, minimal residual disease (MRD) monitoring, patient stratification, trial enrollment, and the development of companion diagnostics. For 25 years, we have stood at forefront of precision diagnostics, and we’re just getting started! 

Remote Position – Southern California Region.  As a Senior Biostatistician at Invivoscribe you will be responsible for the design of studies and analysis of data that could be submitted as part of an IVD application.  You will ensure that product research and development is performed in a manner that complies with applicable regulations and industry standards.  

Core Responsibilities Include:

• Make detailed observations and evaluation of clinical trials and basic research.
• Apply appropriate statistical tools to ensure that experiments are designed properly.
• Apply appropriate statistical tools for data analysis.
• Maintain documentation for clear traceability. 
• Interact with clinical investigators to determine protocol design and understand CLSI guidelines.
• Collaborate with R&D teams to ensure that data generated for IVD submission is defendable to regulation agencies. Write test procedures, reports and sections of IVD submissions.
• Support Quality Control team with experiments and investigations.
• Evaluate databases and statistical analysis programs and interact with technology groups to determine hardware/software compatibility.
• Maintain expertise in state-of-the-art data manipulation and statistical analyses.

You Bring:

• M.S in Applied Statistics and 5+ years’ applicable industry experience.  Other advanced degree advantageous.  Equivalent combination of education and experience may be considered.    
• Proficient in at least one statistical analysis software package; SAS, JMP, R.   
• Understanding of biology, assay development and clinical trials.
• Experience communicating to staff at different levels of experience in statistical analysis.
• Proficient in Microsoft Office Suite (Word, Outlook, Excel and PowerPoint), and the ability to learn new software programs.

 We Bring:

• A beautiful modern headquarters centrally located in San Diego, California.
• A safe, fully-vaccinated, work environment.
• A diverse and inclusive work environment where you will learn, grow, and make new friends.
• Competitive salaries and bonus program, amazing benefit options, a 401k plan with a fully vested employer match, and generous time off benefits that include floating holidays enabling you to take that year-end holiday week, your birthday, your dog’s birthday – you decide!

Evidence of COVID-19 vaccination will be required as a condition of employment.

Invivoscribe is an Equal Opportunity Employer.