Statistician

Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world. The Impact You Will Make The Statistician role is a pivotal position within our pharmaceutical organization, you will be responsible for ensuring compliance with FDA guidance while driving the adoption of state-of-the-art technologies. In this role you will develop and implement statistical methodologies to support various projects, including product development, quality control, and production processes. Role Responsibilities ​​​Subject Matter Expert (SME) for Regulatory Affairs, responsible for representing the company in responses to regulatory agencies and customer inquiries.  ​Statistical Analysis: Design and conduct statistical analyses for production processes, product development, and quality control, ensuring compliance with FDA guidelines.  ​Data Architecture: Develop and maintain data models, data flows, and data integration processes to support data-driven decision-making.  ​AI and Advanced Analytics: Drive the adoption of AI and advanced analytics techniques to improve data analysis and insights.  ​Acceptance Sampling Plans and OC Curves: Develop and implement acceptance sampling plans and Operating Characteristic (OC) curves to ensure product quality and compliance with regulatory standards  ​Collaboration: Work closely with cross-functional teams, including R&D, quality assurance, production operations and IT, to understand data requirements and deliver innovative solutions.  ​Data Governance: Establish and enforce data governance policies and procedures to ensure data quality, consistency, and security.  ​Training and Support: Provide training and support to team members on statistical principles, data architecture, and the use of analytical tools.  ​Develop and maintain procedures for monitoring manufacturing processes, including the use of production process control charts, to identify, analyze, and interpret trends or patterns in complex data sets. This includes applying techniques such as Control Charts, Ppk, Cpk, Nelson Rules, and Normality assessments​​  Basic Qualifications ​​Bachelor's or Master's degree in Statistics, Biostatistics, Data Science, or a related field.  ​Minimum of 5 years of experience in statistical analysis   ​Strong statistical skills with the ability to identify, organize, analyze, and disseminate significant amounts of information with attention to detail and accuracy  ​Preferred experience with Acceptance Sampling Plans, OC Curves, Confidence Intervals and Equivalence Testing  ​Preferred experience with FDA guidelines and regulatory requirements.  ​Experience with data architecture, including SQL, ELT processes.   ​Preferred proficiency in statistical tools such as R, Minitab, and PowerBI.  ​Strong knowledge of AI and advanced analytics techniques.  ​Familiarity with data governance and data quality frameworks.