Role Description The non-clinical Statistician will employ statistical design, tools, and techniques to support process, analytical method and formulation development of medical or pharmaceutical products throughout their lifecycle. Key Responsibilities • Collaborate with subject matter experts to design experimental studies, plan and perform statistical analysis, and document results in technical reports, in support of business decisions, regulatory submissions and compliance. • Provide statistical support for a wide range of non-clinical applications, including • Particle size and distribution • In-vitro bioequivalence assessments • Analytical method optimization and validation • Process development and platform characterization • Stability studies to understand, control, and ensure product quality • Ensure compliance with regulatory and ISO requirements for the statistical methods employed. • Develop, implement, and maintain statistical tools used to support product life cycle activities. • Promote good statistical practice across the team and mentor colleagues in statistical techniques and software tools. • Stay up to date on best practices, industry trends, and regulatory guidance. • Support other non-clinical statistical applications, when needed. • Support regulatory audits by responding to questions during on-site inspections and providing written responses to clarify statistical approaches or perform additional analyses. Qualifications • Doctorate Degree in Statistics or a related field plus 2 years minimum of relevant applied statistics experience OR • Master’s Degree in Statistics or a related field plus 5 years minimum of relevant applied statistics experience OR • Bachelor’s Degree in Statistics or a related field plus 10 years minimum of relevant applied statistics experience. • Proficient in non-clinical applications, including particle size and distribution, in-vitro bioequivalence assessments, analytical method optimization and validation, process development and platform characterization, and stability studies to understand, control, and ensure product quality. • Experience and/or training in design of experiments, including optimization or robustness experimental designs. • Proficient in statistical techniques commonly used in pharmaceutical manufacturing operations, such as • Statistical Process Control • Process Capability Analysis • Measurement System Analysis • Acceptance Sampling • Non-linear and Linear Regression • Significance Testing • Simulation • Skills in machine learning or Bayesian methods are a plus. • Proficient in SAS and/or R programming including data manipulation, macros, functions, statistical and graphical packages, and quality output production; JMP or R-Shiny skills are a plus. • Good understanding of pharmaceutical development and CMC activities in a regulatory context, including GMP and Quality by Design framework. • Excellent communication and collaboration skills. • Demonstrated ability to work independently and pro-actively to deliver top quality work product. Benefits • Home-based remote working opportunities. • Work/life balance as well as flexible schedules. • Collaborating with motivated, high-performance, statistical and research teams. • Technical training and tailored development curriculum. • Research opportunities that match your unique skillset. • Promising career trajectory. • Job stability long-term engagements and re-deployment opportunities. • Focus on bringing new therapies to market rather than project budgets and change orders. • Experience with regulatory submissions. • Engaging, fast-paced environment. • Good work-life balance. Apply To This Job