Senior Pharmaceutical Industry Statistician Job at Tunnell Consulting in, Cleveland, OH

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  • Tunnell Consulting in
  • Cleveland, OH

Job Description

We are currently seeking a highly skilled Senior Statistician with extensive experience in pharmaceutical investigations for a project with one of our clients. Project is estimated to be 4-8 weeks in length (with potential for extension). This is a hybrid role, with travel to client site approximately 75% of the time (minimum 3 weeks onsite). Our client is based in the greater Cleveland, Ohio area.

Senior Statistician


Role Summary

The ideal candidate will have a strong background in advanced statistical methodologies, including Variance, Multivariance and Co-variance analysis, control charts and risk assessment, and will play a key role in supporting Manufacturing, and regulatory compliance activities.

Key Responsibilities


  • Design, implement, and analyze complex statistical models for pharmaceutical Manufacturing and R&D investigations.
  • Produce Control Charts to determine any patterns in the manufacturing process.
  • Conduct variance, multivariance analysis con-variance to identify patterns, correlations, and predictive insights.
  • Perform risk assessment and mitigation strategies for investigational studies.
  • Collaborate with cross-functional teams including R&D, regulatory, and quality assurance to ensure manufacturing efficiency and compliance.
  • Prepare detailed statistical reports and present findings to stakeholders.
  • Support decision-making through robust data interpretation and visualization.


Qualifications
  • Advanced degree (Masters or Ph.D.) in Statistics, Biostatistics, or a related field.
  • Proven experience in pharmaceutical R&D environments.
  • Expertise in variate, multivariate and co-variate analysis and risk modeling.
  • Proficiency in statistical software; experience with JMP strongly preferred.
  • Experience with Control Charts strongly preferred
  • Strong analytical, problem-solving, and communication skills.
  • Ability to manage multiple projects and meet deadlines in a fast-paced environment.


Preferred Skills
  • Familiarity with regulatory guidelines (FDA, EMA).
  • Knowledge of experimental design and quality by design (QbD) principles.
  • Experience with other statistical tools (SAS, R, Python) is a plus.



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