• 19-Sep-2017 to 18-Nov-2017 (CST)
  • Morrisville, NC, USA
  • Full Time

The statistician will be responsible for driving clinical development forward by working with the clinical, management, preclinical, and nonclinical development teams. The statistician will be responsible for developing the data management and statistical strategy for Novan's suite of assets, including working with senior management and advisory boards to develop program plans, individual study designs including sample size calculations, and overseeing data management and statistical analyses performed by our CRO partners. The position will require innovative thinking, including decisions regarding appropriate use of eDC and remote data monitoring as well as the possible use of adaptive designs, enrichment designs, and advanced statistical methodology to best elucidate the product's characteristics and position the development for regulatory success. Ability to see the big picture is essential for success in this position.

On a day-to-day basis, the statistician will interact with the CRO data managers and statisticians to develop and approve data management and statistical analysis plans, review data and TLFs, contribute to CSRs, and help select CROs for studies. The statistician will also contribute to clinical protocols, including sample size calculations and endpoint selection. Support for scholarly publications of Novan's work is expected, and the ability to provide statistical support for process development and optimization and quality control development would be helpful. Other duties may be assigned as needed.

The candidate must have:

PhD in statistics or biostatistics or related field with at least 5 years of clinical development experience, or MS in statistics or biostatistics or related field with at least 10 years of clinical development experience

  • Experience with writing DMPs
  • Experience with writing SAPs
  • Experience developing TLFs
  • Experience with writing CSRs
  • Experience interacting with the FDA
  • Knowledge of eDC and Remote Data Monitoring
  • Knowledge of SAS or R
  • Strong ability to communicate statistical concepts to nonstatisticians
  • Sense of urgency, and self-motivated

Additional Experience/Skills:

  • Experience with adaptive designs and population enrichment
  • Experience in modeling and simulation
  • Process optimization experience, including response surface designs
  • Nonparametric statistical knowledge
  • Experience in topical skin diseases


This position requires occasion travel (< 1 day per month).

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