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Statistician

3 months ago

Fort Washington, United States Net2Source Inc. Full time

SME Statistician

Fort Washington, PA

6+ Months Role


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.


Statistician 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.


Statistician 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.

Statistician 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.