Remote, Biostatistician

GForce Life Sciences Remote
remote data medical analysis director analytical programming biostatistics science regulatory statistics modeling design
November 11, 2022
GForce Life Sciences
Washington, Washington DC
FULL_TIME

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


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