Remote; Gaithersburg or Frederick, MD
Contract Duration: 12-36 months
Rate: 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 Operations (GTO) will work under the direction of the GTO statistician.
• Responsible for providing statistical support across a broad range of technical areas, including analytical, process development, drug substance 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 oversight for the internal and external projects that GTO leads/supports.
• Provide statistical support for GTO and global company sites
• Maintain models to summarize current level of process and product understanding
• Implement advanced data mining and monitoring tools to track process performance and product quality for commercial production across sites
• Apply statistical methods to facilitate better decision making and improve business operation
• Collaborate with statisticians in other departments for improvement and standardization of statistical methods
• Collaborate with colleagues from other divisions or departments to achieve corporate goals
• Lead or participate in establishing global statistical guidelines
• Represent GTO on cross-project initiatives such as specification strategy, 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 SAS and JMP statistical software required; R, Matlab, or other software a plus
• Expertise in applied statistical methodologies including linear and non-linear mixed models, statistical intervals, experimental design, probability methods, 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 methods
• Derivation of acceptance criteria
• 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 commercial products
• Stability data analysis
• Contribute to the development of novel statistical methods to resolve problems in manufacturing operations and analytical testing
• Apply advanced statistical principles, theories, and concepts to make 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 projects and processes
• Excellent oral and written communication skills
• Work under limited consultative direction toward predetermined long-range goals and objectives.
Salary: USD 100000 - 130000 per year
Experience: 3 years required