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Job Description: This position is responsible for providing appropriate statistical assistance and training to service clients in Global Manufacturing & Supply (Client). This position also assists R&D and other company business units in study design and statistical analyses, as needed.
MAJOR DUTIES AND RESPONSIBILITIES
1. Develops and selects appropriate statistical methods for the design and analysis of studies and programs in order to assure batch compliance and prevent rejections, reworks, complaints, and product recalls on a worldwide basis. For example, determining specifications, process capability, sampling plans and expiry/retest periods.
2. Conducts thorough and careful analysis of data, gathers critical information, driving business decision making based on analytical findings and business needs.
3. Builds and fosters relationships with customers, stakeholders, and support groups globally to understand their statistical needs and determines sound statistical techniques for use.
4. Demonstrates strong statistical skills while thinking in a clear, decisive manner. Reaches independent, logical solutions.
5. Represents Global Statistics at product development, product protocol, and management meetings.
6. Contributes to the globalization, improvement and standardization of processes, procedures and systems in relation to Statistics while maintaining flexibility where required.
7. Furthers the statistical awareness and statistical process control competency of other functional groups; participates in their training and development, as required.
8. Creates, communicates, and supports the highest commitment to quality and compliance.
9. Supports the company BioPharma Behaviors.
This is intended to be a general job description and should not be construed as all inclusive.
KNOWLEDGE / SKILL
1. Degree in Statistics, Applied Mathematics, or Engineering majors with significant academic training in Statistics.
2. Proficiency in one or more major statistical software packages (e.g., SAS, R, MINITAB, and JMP).
Experience / Knowledge Desired:
1. Ability to work with a wide range of technically and culturally diverse individuals.
1. Demonstrated ability to collaborate with various stakeholders to understand business goals, gather data, and provide insights that lead to actionable outcomes through effective study design and statistical analysis.
2. Preferred knowledge of FDA/EMEA cGMPs and knowledge of other global regulatory compliance guidelines (e.g. ICH) for drug manufacturing, packaging and distribution.
3. Preferred knowledge of Quality Assurance principles including cGMP documentation practices, policies and procedures, and quality systems.
4. Ability to quickly adapt to changing priorities and generate innovative solutions in a fast-paced and multi-tasks environment.
5. Strong detail orientation and problem solving skills
6. Highly organized with the ability to track and prioritize numerous simultaneous tasks.
7. Able to work independently or as a team member to meet goals, objectives and commitments.
8. Demonstrates ability to effectively communicate technical information in an understandable, rational, and concise manner.
9. Some background in the sciences to facilitate a subjective understanding of the problems at hand.
Additional Job Requirements:
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Axelon Services, Corp is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity, national origin, disability, or protected veteran status.