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Clinical Data Statistician

Background

As part of Koneksa support of clinical studies, we perform analyses of large volumes of patient reported and device generated data. This includes analyses to test for intervention effects, compute relevant statistics, and assess and correct for circadian patterns. These analyses must be then reported to our customers clearly and succinctly with beautiful visualizations.

Responsibilities

  • Your will have three responsibilities:
  • Generate statistical analysis plans
  • Execute analyses
  • Create reports

In the course of executing these responsibilities, you will work closely with the team and customers. You should be fluent enough in statistical methods to recommend appropriate methods to customers and to translate the results into relevant findings for clinical teams.

The analyses performed by the Koneksa team will be used in Koneksa scientific reports that will be submitted to academic journals. And, most importantly, the results of these analyses must ultimately be ready for submission to the FDA in support of new drug applications.

Because this work is so important to our customer and their patients, we require your excellence.

Requirements

  • You should be a statistician/machine learning maven/data scientist who doesn’t fear a lot of data.

You should understand:

  • Standard statistical methods (what’s an ANOVA? Logistic regression)
  • Time series analysis (Cox models? ARIMA models?)
  • Data QC (can you read a file with 10 million rows and identify the useless ones?)
  • Data visualization (turning data into art)
  • Report generation (the final product)

Bonus

  • Machine learning (Know what a hyperplane is? Can you talk intelligently about perceptrons?)
  • Work in a regulatorily sensitive environment (Healthcare, Finance, etc)
  • Experience with clinical reporting standards (e.g. ICH E3)
  • Work with CDISC data interchange formats
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