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Lead Statistician

2 months ago


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

Job Title: Lead Statistician

Job Location: Fort Washington, PA

Job Duration: 6 months+

Overview:

  • The Lead Statistician serves as the Subject Matter Expert (SME) in non-clinical statistical methodologies within the organization.
  • This position is responsible for identifying and applying established industry practices related to the effective use of statistical analysis. Collaborating with colleagues, the Lead Statistician will implement statistical, mathematical, and graphical techniques to support innovation, development, validation, and operational processes in drug product manufacturing and packaging.
  • The ideal candidate will demonstrate a commitment to advancing knowledge in statistics and quantitative sciences, while remaining informed about industry developments through active participation in professional organizations. The organization will benefit from enhanced risk management practices that leverage data-driven decision-making to achieve favorable project outcomes.
  • This role will ensure uniformity across the supply chain by designing and executing a comprehensive capability-building program focused on the application of statistical techniques, which includes evaluating statistical software and methodologies for suitability.
  • The candidate must be adept at articulating sound scientific concepts, providing evidence-based assessments of risk and impact, and constructing logical arguments for management, regulatory bodies, and cross-functional teams.
  • Active participation in project teams is essential, including the selection of scientifically valid data collection tools to ensure that analyses adequately address confounding factors and uncertainties, leading to defensible statistical conclusions.
  • Creativity in developing alternative analytical strategies for practical applications is highly valued.

Key Responsibilities:

  • Operate under limited supervision while adhering to all applicable laws, regulations, and company policies, ensuring:
  • Quality and compliance in all actions taken.
  • Participation in relevant training sessions as required for the role.
  • Strict adherence to established procedures.
  • Upholding the highest standards of integrity in all tasks performed.
  • Timely identification and reporting of any deviations in the workplace.
  • Fostering a culture of employee engagement and commitment to excellence.
  • Serving as the primary global contact for the appropriate application of statistical methods to resolve technical challenges within internal facilities and with external manufacturing partners.
  • Ensuring consistency throughout the supply chain by developing and delivering training programs aimed at enhancing the statistical capabilities of non-statisticians.
  • Collaborating across the organization to positively influence project outcomes.
  • Working with project teams to determine suitable study designs and data collection strategies to meet specific objectives.
  • Identifying, designing, and evaluating the effectiveness of training initiatives to enhance statistical skills among non-statistical personnel.
  • Engaging with external partners to manage workload effectively.
  • Contributing to various governance committees as needed.

Qualifications:

  • Education: A Bachelor's degree (or equivalent) is required; a Master's degree or PhD in Statistics or a related field is preferred.
  • Experience: A minimum of 8 years of relevant experience is required, with at least 6 years in Statistics or related Quantitative Sciences. Experience in applied non-clinical statistics for manufacturing, particularly in pharmaceuticals, is ideal. Supervisory experience is strongly preferred.
  • Physical Demands: This role involves office deskwork, including sitting, walking, and using a phone and computer. Occasional lifting of up to 30 lbs may be required. Some travel may be necessary based on business needs.

Knowledge, Skills, and Abilities:

  • Proficiency in statistical methods such as ANOVA, regression analysis, variance components analysis, capability analysis, sampling plans, control charts, exploratory data analysis, and experimental design is essential.
  • Familiarity with mixed effects modeling and multivariate analysis is beneficial.
  • Ability to differentiate and communicate between statistical significance and practical significance.
  • Expertise in statistical software such as SAS, JMP, Minitab, or R; proficiency in Minitab is particularly advantageous.
  • Understanding of pharmaceutical manufacturing processes is preferred.
  • Knowledge of current Good Manufacturing Practices (cGMPs) is beneficial, especially experience in Quality Assurance or Technical Operations.
  • Strong communication and negotiation skills are necessary for effective interaction with internal and external stakeholders.
  • Demonstrated facilitation and organizational skills are required.
  • Excellent oral and written communication abilities are essential.
  • Understanding of team dynamics and organizational behavior is important.
  • Experience in conflict management and resolution is preferred.