Senior Statistician for Commercial Support

2 weeks ago

Fort Washington, Pennsylvania, United States Integrated Resources, Inc ( IRI ) Full time

Position Overview:

The Senior Statistician for Commercial Support serves as the Subject Matter Expert (SME) in non-clinical mathematics and statistics within Integrated Resources, Inc (IRI).

This role is pivotal in identifying and applying established industry methodologies that promote the effective use of mathematics and statistics. In collaboration with colleagues, the Senior Statistician will deploy statistical, mathematical, and graphical techniques to foster innovation, development, validation, and support for drug product manufacturing and packaging processes.

The ideal candidate will possess a proven track record of advancing knowledge in mathematics, statistics, and computational sciences, while remaining abreast of industry developments through active participation in professional organizations. The organization will benefit from enhanced risk management practices that increasingly leverage data-driven decision-making to achieve favorable project outcomes.

Key Responsibilities:

Under minimal supervision and in compliance with all applicable regulations and company policies, the incumbent will:

  • Uphold quality and compliance in all actions.
  • Participate in training programs relevant to the role.
  • Adhere strictly to established procedures.
  • Demonstrate integrity in all tasks performed.
  • Promptly identify, report, and rectify any deviations observed in the workplace.
  • Foster a culture of employee engagement and commitment to excellence.
  • Act as the primary global contact for the Consumer supply chain regarding the application of mathematics and statistics to resolve technical challenges.
  • Ensure consistency across the supply chain by designing and implementing a capability-building program for mathematics/statistics, which includes reviewing statistical software and procedures for suitability.
  • Collaborate across the organization to positively influence project outcomes.
  • Construct and present sound scientific concepts, evidence, risk assessments, and logical arguments to management and regulatory bodies.
  • Work with project teams to select appropriate study designs and data collection strategies to meet objectives.
  • Identify, design, deliver, and evaluate training programs to enhance the statistical skills of non-statisticians.
  • Contribute to project teams in selecting appropriate data collection instruments to ensure robust analysis.
  • Engage with external partners to manage workload effectively.
  • Develop innovative analysis strategies for practical applications.
  • Participate in various governance committees as needed.

Qualifications:

Education: A Bachelor's degree (or equivalent) is required; a Master's degree or PhD in Statistics or related Quantitative Sciences is preferred.

Experience: A minimum of 8 years of experience is required, with at least 6 years in Statistics or related Quantitative Sciences preferred. Experience in applied non-clinical statistics for manufacturing, particularly with pharmaceutical solids, liquids, and packaging, is ideal. Supervisory experience is highly desirable.

Knowledge, Skills, and Abilities:

  • Expertise in ANOVA, regression, variance components analysis, capability analysis, sampling plans, control charts, exploratory data analysis, and experimental design.
  • Familiarity with mixed effects modeling and multivariate analyses.
  • Ability to differentiate and communicate between statistical and practical significance.
  • Proficiency in statistical software such as SAS, JMP, Minitab, or R, with a strong preference for Minitab.
  • Understanding of pharmaceutical manufacturing processes is preferred.
  • Knowledge of cGMPs, with experience in Quality Assurance or Technical Operations preferred.
  • Strong communication and negotiation skills for effective interaction with internal and external stakeholders.
  • Demonstrated facilitation and organizational skills.
  • Excellent oral and written communication abilities.
  • Understanding of team dynamics and organizational behavior.
  • Experience in conflict management and resolution.

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