Remote, Biostatistician

Consultant, Biostatistician Director, Medical Device

Summary

Our client, a global medical device company, a market leader in diagnostic imaging with systems for computed tomography, magnetic resonance imaging, molecular imaging, X-ray products, ultrasound systems, and imaging IT, is seeking a Biostatistician Director to support the Innovation Team. This position will report to the Senior Director, Pre-Market Biostatistics.

Duties / Expectations of Role

• Developing and applying statistical analysis strategies, in collaboration with internal and external partners responsible for evidence generation and verification protocols, to demonstrate value of key medical diagnostic products
• Developing and innovating solutions to novel clinical science problems that utilize data obtained from controlled clinical trials and/or real-world sources to verify and validate performance claims on new diagnostic assays
• Working cross-functionally with internal and external partners to deliver scientifically and statistically valid evidence obtained from registrational and non-registrational studies
• Serving as a subject matter expert on product development teams in statistical analysis of analytical and clinical studies
• Ensuring development of rigorous study designs and analysis plans, define clear and attainable statistical and scientific endpoints that demonstrate value locally and globally; determine best ways to present data to maximize interpretation and value to customers
• Communicating updates to internal and external stakeholders; participating in internal and external meetings or forums
• Staying current with advances in statistical methods, applications, and regulatory requirements

Mandatory Requirements

• PhD in statistics or Biostatistics; Exceptional candidates with other STEM degrees bridging biological science will be considered
• At least 10 years' experience supporting analytical and clinical verification and validation studies within the in vitro diagnostics industry
• Strong knowledge and demonstrated experience in statistical modeling and simulation, clinical trial study design, statistical programming (SAS, and data wrangling
• Demonstrated progressive responsibility and statistical expertise to support analytical and clinical verification studies from planning through regulatory submission
• Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, survival analysis, and associated sample size calculations
• Familiarity with diagnostic clinical trial statistics is required
• Proficiency in statistical programming (SAS, R) and query of relational database systems (SQL)
• Experience with extraction of data and reporting within Clinical Data Management systems (e.g. Medidata RAVE, Medrio, Oracle Clinical)
• Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solutions to novel problems
• Familiar with FDA guidelines and CLSI guidelines applicable to medical diagnostics is required
• Experience with analysis of complex data from multiple source
• Ability to work independently and in project teams
• Highly motivated and driven to exceed expectations
• Strong communication skills in English, written and spoken
• Strong ability for public speaking in audiences with mixed backgrounds
• Able to distill complex statistical concepts in simpler terms to generalized audiences

Nice to Have Requirements

Certification in SAS programming is a plus

Term & Start

• Contract to Hire
• Start Date: ASAP

Benefits

• 401(k) matching
• Employer contributed competitive health benefits (medical, dental, vision)
• Philanthropy driven culture
• Consultant engagement social activities