Statistician - Process Development

About the role

Apply a complete understanding of theories and principles to biologics development; demonstrate a thorough understanding of processes/systems related to the manufacturing of drug substances. Provide statistical expertise, study designs, and data analysis while communicating data-driven decisions for biologics process improvements, process understanding, method development, technology transfer and validation, and stability studies in collaboration with Catalent personnel and clients. Suggest innovative solutions to statistical problems and the methods to integrate the solutions into Process Development. Provide sample size calculations and review protocols for completeness, appropriateness of method and protocol design, DOE, and sound statistical analysis. Provide randomization schemes and appropriate documentation; develop statistical analysis plans. Prepare and review reports; contribute to the statistical methods section and verify for completeness and consistency for report. Communicate study results and statistical concepts in internal and external meetings; also serve as a mentor to staff in teaching statistical methods and their application to biologics development. Maintain a thorough understanding of statistical and data science skills by learning new methodologies and applications to biologics development, suggesting which methods to use in analysis, and justifying the methods selected for client and regulatory agency review. Other duties as assigned. The Candidate: Bachelor's Degree required in a STEM or related field with at least 3+ years of experience in engineering, statistics, or data science Master's Degree in STEM field is preferred, ideally with 1+ years of experience Skilled in streamlining and automating data processes using Visual Basic and .NET, with robust proficiency in statistical and analytical tools including MiniTab, JMP, SAS, Tableau, and Spotfire, as well as advanced Microsoft Excel Understanding and demonstrated knowledge/application of software programs used to support statistical process control (SPC) and DOE Knowledge and experience working in a CGMP environment is preferred with an understanding of the unique data from biologics process development and manufacturing Experience with continued process verification (CPV) preferred Physical requirements: Individual must be able to see, hear, read, and write clear English. Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities. Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidays Generous 401K match Medical, dental and vision benefits Tuition Reimbursement - Let us help you finish your degree or start a new degree! Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catale