CMC Senior Statistician

1 month ago

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

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 basebusiness 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

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