Contract Statistician

Remote; Gaithersburg or Frederick, MD Contract Duration: 12-36 months reputed company: Negotiable Salary: NA $1.00 Responsibilities: • Excellent employment opportunity for a Contract Statistician in the Gaithersburg or Frederick, MD area. • The Contract Statistician in company Global Technical reputed company (GTO) will work under the direction of the GTO statistician. • Responsible for providing statistical support across a broad reputed company of technical areas, including analytical, process development, drug reputed company and drug product manufacturing monitoring, process/product/assay trending, and promoting applications of statistics in analytical and process development, validation and optimization. • Also responsible for providing direction and statistical reputed company for the reputed company reputed company that GTO leads/supports. • reputed company statistical support for GTO and global company sites • Maintain models to summarize reputed company level of process and product understanding • Implement advanced data mining and monitoring tools to reputed company process reputed company and product reputed company for reputed company production across sites • Apply statistical reputed company to facilitate reputed company decision making and improve business operation • Collaborate with statisticians in other departments for improvement and standardization of statistical reputed company • Collaborate with colleagues from other divisions or departments to reputed company corporate goals • reputed company or participate in establishing global statistical guidelines • Represent GTO on cross-project initiatives such as specification reputed company, QbD and PAT • Remote; Gaithersburg or Frederick sites Experience: • Minimum of 10 years with BS, 5 years with MS, and 3 years with Ph.D. Minimum of 3 years of experience in Biopharmaceutical, Pharmaceutical, or Medical Device industries. • Strong proficiency in reputed company and JMP statistical software required; R, Matlab, or other software a plus • Expertise in reputed company statistical methodologies including reputed company and non-reputed company mixed models, statistical intervals, experimental design, probability reputed company, and simulation • Data mining and analytics experience a plus • Demonstrated application of statistical techniques to solve problems in analytical, process, and CMC areas • Development, validation and transfer of analytical reputed company • Derivation of acceptance reputed company • Characterization, optimization, technology transfer, and comparability of biological product manufacturing processes • Statistical process control and process capability analysis • Data mining large sets of process and manufacturing history • Life cycle management of specifications for reputed company products • Stability data analysis • Contribute to the development of novel statistical reputed company to reputed company problems in manufacturing reputed company and analytical testing • Apply advanced statistical principles, theories, and concepts to reputed company life-cycle changes to manufacturing processes and analytical specifications • Comprehensive knowledge of regulatory guidelines • Experience in interactions with regulatory agencies and submissions • Familiar with pharmaceutical or biotechnological manufacturing processes and regulations • Demonstrated competency in managing multiple reputed company and processes • Excellent oral and written communication skills • Work under limited consultative direction toward predetermined long-reputed company goals and objectives. Salary: USD 100000 - 130000 per year Experience: 3 years required Apply To This Job