Senior Manager, Nonclinical Statistics

Lake County, IL, US
Aug 09, 2019
Required Education
Masters Degree/MBA
Position Type
Full time

The Senior Manager in Statistics is responsible for providing statistical support across a broad range in nonclinical areas with a focus on Chemistry, Manufacture and Control (CMC), expanding and broadening the application of Biostatistics. He/she is also responsible for helping the group head build the group infrastructure (e.g., developing SOPs) and mentor junior statisticians or interns.

Major Job Responsibilities:

  • Serve as a statistical lead in one of the nonclinical areas.
  • Apply statistical techniques to facilitate better decision-making and improve business operation.
  • Regularly interact with management of different levels in strategy meetings. Contribute to strategic planning to ensure statistically optimized non-clinical development plans and assist in the creation of strategic objectives for regulatory filings.
  • Participate in the planning/design, conduct, analysis, and interpretation of non-clinical studies and regulatory submissions with a focus on CMC areas.
  • Collaborate with colleagues from other departments to ensure compliance with regulations and help implement regulatory initiatives such as Quality by Design and process validation.
  • Develop statistical tools to streamline process development, QC testing and troubleshooting.
  • Prepare statistical courses and provide training to scientists.
  • Develop and deliver statistical and scientific publications and present internally and externally.
  • Participate in establishing departmental and non-clinical SOPs and guidelines.
  • Collaborate with other statisticians in improving and sharing statistical approaches.

Level will be based on education & years of experience.


  • MS or PhD in Statistics or a related field with a minimum of 8-10 years (MS) or 4-6 years (PhD) experience.
  • Must have comprehensive knowledge of statistical principles and methodologies in drug research and development, and proficiency in statistical software such as SAS and R. Knowledge of Minitab, JMP and other scientific computation software a plus.
  • Must have excellent interpersonal and effective verbal and written communication skills.
  • Strong leadership skills and experience in working/managing in an international team.
  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Raises the bar and is never satisfied with the status quo.
  • Competent in experimental design, descriptive and inferential statistics, biometrics/ biopharmaceutical applications and computer programming
  • Pharmaceutical or related industry experience with nonclinical, clinical or pharmacology studies, as appropriate, including experience and understanding of drug development in the regulated environment preferred
  • Learns fast, grasps the 'essence' and can change the course quickly where indicated.