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Senior Statistician- CMC

3 months ago

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

Job Title: Senior Statistician

Job Location: Fort Washington, PA

Job Duration: 6 months+


Description:

  • The Commercial Support Statistician is Consumer's Subject Matter Expert (SME) in non-clinical mathematics/statistics.
  • The role will identify and implement tested industry methodologies associated with the appropriate use of mathematics and statistics. Collaborating with her/his peers, this role will identify and deploy statistical, mathematical, and graphical approaches for innovation, development, validation and base business support of drug product manufacturing and packaging processes.
  • The ideal candidate will have a demonstrated ability to facilitate continued growth in mathematics, statistics and/or computational/quantitative sciences and the ability to stay current with industry trends through involvement with external/professional organizations. The organization will benefit from risk management that increasingly utilizes data-based decision making and influence positive project outcomes.
  • Ensures consistency throughout the supply chain by designing and delivering the capability enabling program for the use of mathematics/statistics through broad based skill development and targeted mentorship. Includes the review of statistical software packages and procedures for appropriateness.
  • Able to construct and deliver sound scientific concepts, evidence, assessments of risk and impact, and logical arguments to management, regulatory agencies and cross-functional partners.
  • Actively contributes to project teams (including investigations) to identify scientifically appropriate data collection instruments to ensure final analysis accounts for unavoidable confounding factors and uncertainty, and statistical conclusions are defendable.
  • Able to develop creative/alternative analysis strategies for real-world applications.


Responsibilities:

  • Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines, this position requires to:
  • Ensure quality and compliance in all my actions by: All employees
  • Attend GMP training on the schedule designated for my role and as appropriate for my role
  • Adhere to strict compliance with procedures applicable to my role.
  • Exercise the highest level of integrity in the tasks that I perform.
  • In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
  • Embrace a behavior of employee involvement and commitment to doing the job right the first time.
  • Be the point of global contact for the Consumer supply chain for the appropriate use of mathematics/statistics to solve technical issues at our internal plants as well as external manufacturing partners.
  • Ensures consistency throughout the supply chain by designing and delivering the capability enabling program for the use of mathematics/statistics through broad based skill development and targeted mentorship. Includes the review of statistical software packages and procedures for appropriateness.
  • Able to collaborate across the entire organization to influence positive project outcomes.
  • Able to construct and deliver sound scientific concepts, evidence, assessments of risk and impact, and logical arguments to management, regulatory agencies and cross-functional partners
  • Able to work with project teams (including investigations) to select appropriate study design and data collection plans to meet defined objectives
  • Able to identify, design, deliver and measure effectivity of mass and individual training to advance the skillset of non-statisticians in the appropriate use of statistical techniques
  • Actively contributes to project teams (including investigations) to identify scientifically appropriate data collection instruments to ensure final analysis accounts for unavoidable confounding factors and uncertainty, and statistical conclusions are defendable
  • Able to work with external partners to manage workload
  • Able to develop creative/alternative analysis strategies for real-world applications
  • Able to contribute via ad hoc membership for numerous governance committees


IV. Requirements: (List types of requirements and typical years required)

  • Education: Bachelor’s degree (or equivalent) required. Master’s degree or PHD in Statistics or related
  • Quantitative Sciences preferred.
  • Experience: 8+ years’ experience required with 6 years experience in Statistics or related Quantitative
  • Sciences preferred. Applied non-clinical statistics for manufacturing; ideally experience with Pharmaceutical solids, liquids and packaging. Supervisory experience is strongly preferred.
  • Physical Demands: Office deskwork, requiring sitting, walking, using phone & computer. May lift up to 30 lbs occasionally. This role may require up to 25% travel based on business needs.


Knowledge, Skills and Abilities:

  • Expertise with ANOVA, regression, variance components analysis, capability analysis, sampling plans, control charts, exploratory data analysis and experimental design required.
  • Familiarity with mixed effects modeling and multivariate analyses.
  • Ability to rationalize and communicate the difference between statistical and practical significance
  • Proficiency with statistical software such as SAS, JMP, Minitab, or R. Minitab strongly preferred
  • Familiarity with pharmaceutical manufacturing processes (experience preferred)
  • Knowledge of cGMPs (experience in Quality Assurance or Technical Operations preferred)
  • Demonstrated strong communication/negotiation skills to interact with internal and external partners.
  • Demonstrated strong facilitation and organizational skills
  • Excellent oral & written communication skills
  • Understanding of team and organizational dynamics
  • Experience and demonstrated results managing and resolving conflict, and overcoming resistance