Job Description
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. Apply tot his job