Senior Pharmaceutical Industry Statistician

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.

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

• 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, multi variance 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.

• Advanced degree (Master’s 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.

• 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.