Manager of Diagnostic Statistics

Organization
Precision for Medicine
Job Location
8425 Precision Way
Frederick, MD 21701
Benefits

Medical, Dental, Vision, Flexible Spending Accounts, 401k, Commuter Benefits, Health Savings Account, Life Insurance, Short and Long Term Disability, Paid Holidays, Paid Vacation

Job Description

We are pioneers at technology enabled services for biomarker data management, translational informatics, and diagnostics sciences. Turning complex biomarker data into cutting edge diagnostics to aid in early diagnosis or treatment decisions is a foundational aspect to delivering on the promise of modern biomarker-driven clinical research and the role of a Manager of Diagnostics Statistics is critical to enabling the delivery of precision medicine solutions on time for our clients.

About you:

  • You quickly grasp and accurately apply complex technical concepts
  • You are inquisitive and have a passion for lifelong learning
  • You are flexible and enjoy working in dynamic environments – change is inspiring to you and you can easily adapt when faced with challenges
  • You have a keen ability to size up problems and see the big picture

 

Essential duties include but are not limited to:

  • Design and analysis of analytical (e.g. external reproducibility, LoQ/LoD/LoB) and clinical validation studies
  • Support technical writing (e.g. Statistical Analysis Plans and Reports) for submissions to regulatory agencies (e.g. FDA)
  • Provide guidance on implementation of statistical analysis to support medical device and diagnostics submissions to regulatory agencies to other statisticians
  • Create and/or validate source code in SAS and/or R
  • Interface with internal and external teams as needed
  • Develop documentation and data specifications
  • Participate in research and development activities as appropriate
Requirements

Qualifications:

Minimum Required:

  • Master’s in Biostatistics, Statistics or related field 

 

Other Required:

  • Proficiency in R and/or SAS
  • Excellent communication and interpersonal skills.
  • Team player contributing to a positive, collaborative working environment.
  • Extended work hours may be required to meet business demands.

 

Preferred:

  • PhD in Biostatistics, Statistics or related field.
  • Experience with FDA submission process and FDA guidelines for medical device and/or diagnostic submissions
  • Experience with CLSI guidelines for analytical and clinical validation studies for medical device and/or diagnostics
About Our Organization

Precision for Medicine supports life sciences companies in the use of biomarkers essential to targeting patients more precisely and effectively. Precision applies novel biomarker approaches to clinical research that take advantage of the latest advancements in science and technology, focusing predominantly around genomics, immune-response assays, global specimen logistics, biomarker analytics, and companion diagnostics solutions. Precision for Medicine is part of Precision Medicine Group, with more than 900 employees in over 15 locations in the US, Canada, and Europe.

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