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Statistician for Global Manufacturing & Supply
Ref No.: 18-00685
Location: Devens, Massachusetts
Position Type:Contract
Start Date / End Date: 05/29/2018 to 11/28/2018
Project Description:
This position is responsible for providing appropriate statistical assistance and training to service clients in Global Manufacturing & Supply (GMS). This position also assists R&D and other Client business units in study design and statistical analyses, as needed.
  • 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.
  • Conducts thorough and careful analysis of data, gathers critical information, driving business decision making based on analytical findings and business needs.
  • Builds and fosters relationships with customers, stakeholders, and support groups globally to understand their statistical needs and determines sound statistical techniques for use.
  • Demonstrates strong statistical skills while thinking in a clear, decisive manner. Reaches independent, logical solutions.
  • Represents Global Statistics at product development, product protocol, and management meetings.
  • Contributes to the globalization, improvement and standardization of processes, procedures and systems in relation to Statistics while maintaining flexibility where required.
  • Furthers the statistical awareness and statistical process control competency of other functional groups; participates in their training and development, as required.
  • Creates, communicates, and supports the highest commitment to quality and compliance.
  • Supports the Client BioPharma Behaviors.

Required Skills:
  • Degree in Statistics, Applied Mathematics, or Engineering majors with significant academic training in Statistics. Minimum Ph.D or 2+ for MS.
  • Proficiency in one or more major statistical software packages (e.g., SAS, R, MINITAB, and JMP).
  • Ability to work with a wide range of technically and culturally diverse individuals.
  • 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.
  • Preferred knowledge of FDA/EMEA cGMPs and knowledge of other global regulatory compliance guidelines (e.g. ICH) for drug manufacturing, packaging and distribution.
  • Preferred knowledge of Quality Assurance principles including cGMP documentation practices, policies and procedures, and quality systems.
  • Ability to quickly adapt to changing priorities and generate innovative solutions in a fast-paced and multi-tasks environment.
  • Strong detail orientation and problem solving skills.
  • Highly organized with the ability to track and prioritize numerous simultaneous tasks.
  • Able to work independently or as a team member to meet goals, objectives and commitments.
  • Demonstrates ability to effectively communicate technical information in an understandable, rational, and concise manner.
  • Some background in the sciences to facilitate a subjective understanding of the problems at hand.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Dannielle: