Senior Pharmaceutical Industry Statistician
About the position
Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.
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.
Role Summary: The ideal candidate will have a strong background in advanced statistical methodologies, including Variate, Multivariate and Co-variate analysis, control charts and risk assessment, and will play a key role in supporting Manufacturing, and regulatory compliance activities.
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 variate, multivariate analysis con-variate 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.
Requirements
• 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.
Nice-to-haves
• 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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