Non- Clinical Statistician

Troy - Michigan - United States - Life Sciences & Health Care - Biotechnology - Project Management & Services - Academic Master

General Duties and Responsibilities:
  • Provide statistical expertise to nonclinical CMC drug development activities, with a focus on bioprocess development, quality control, and manufacturing;
  • Provide statistical expertise to support preclinical and animal study design and data analysis;
  • Propose experimental design and analysis strategies, perform statistical analyses, and ensure the statistical integrity of reports;
  • Application of various statistical approaches and innovative thinking to analyze pre-clinical and CMC data;
  • Build out statistical capabilities and propose opportunities for productivity improvements and implementation plans;
  • Develop and deliver statistics courses to nonclinical audiences;
  • Develop and maintain good working relationships with discovery and CMC scientists and external collaborators as part of a multidisciplinary team;
Qualifications and Skills:
  • At least 5 years of experience in the pharmaceutical, chemical, biotechnical, or related controlled manufacturing industry;
Education and Knowledge Requirements:
  • Master or Doctor degree in statistics, mathematics or equivalent science degree;
  • Proficient with statistical modeling and inferential statistics; actively seeks to acquire knowledge;
  • Extensive experience in applied statistics and use of statistical software tools (such as R, JMP, SAS);
  • Experience in designing, executing and analyzing DOE studies and pre-clinical animal studies;
  • In depth knowledge of variance components analysis with nested or crossed mixed-effect modeling for non-clinical stat projects;
  • Knowledge of data dimension reduction analysis for CMC processes characterization;
  • Experience in exploratory data analysis and data visualization;
  • Knowledge and experience in bioequivalence and stability analyses;
  • Knowledge and experience in implementation of statistical process control (SPC);
  • Knowledge of regulatory requirements related to pharmaceutical development and manufacturing;
Skills and Capabilities:
  • Ability to create a clear and concise Strategic view in a complex working environment;
  • Strong analytical capabilities;
  • Strong communication and influencing skills to drive global initiatives;
  • Strong interpersonal capabilities and motivating personality. A team player;
  • Ability to lead successfully in highly matrixed multi-cultural global environment and influence with authority is a definite asset.

Feel free to contact

Arpita Sharma, Account manager

Apply now


  • Vacancy number: PUB203231
  • Location: Troy
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branche: Biotechnology
  • Education level: Academic Master
  • Area of Expertise: Project Management & Services
  • Closing date: Monday, April 29, 2019
Apply now

Feel free to contact


Arpita Sharma

Account manager Brunel Canada Toronto

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