Contract Statistician
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