Statistician IV

Source One Technical Solutions is seeking a Statistician IV with experience in applied non-clinical statistics for manufacturing; ideally experienced with Pharmaceutical solids, liquids, and packaging for an exciting consulting opportunity with a consumer products division of a global pharmaceutical company.

No sponsorships or C2C

Job Title: Statistician IV (Contractor)

Location: Fort Washington, PA (Hybrid)

The contract duration is initially 6-8 months, with a likely extension

40 hours/week, Mon-Fri

Hourly Rate: $100.00 per hour/W2

Description:

• The Commercial Support Statistician is Consumer's Subject Matter Expert (SME) in non-clinical mathematics/statistics.
• 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.
• Facilitate continued growth in mathematics, statistics and/or computational/quantitative sciences, including 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, including the review of statistical software packages and procedures for appropriateness.
• Able to construct and deliver sound scientific concepts, evidence, assessments of risk and impact, logical arguments to management, regulatory agencies, and cross functional partners.
• Actively contributes to project teams (including investigations) to identify scientifically appropriate data collection instruments, ensuring the final analysis accounts for unavoidable confounding factors and uncertainty, and that the statistical conclusions are defendable.
• Able to develop creative/alternative analysis strategies for real-world applications.

Responsibilities:

• Ensure quality and compliance in all actions by all employees.
• Attend GMP training.
• Adhere to strict compliance with procedures.
• Exercise the highest level of integrity.
• In a timely and prompt manner, identify, report, and seek correction for deviations.
• 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 internal plants and external manufacturing partners.
• Ensures consistency throughout the supply chain by designing and delivering the capability enabling programs for the use of mathematics/statistics through broad based skill development and targeted mentorship, including 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, 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 the final analysis accounts for unavoidable confounding factors, uncertainty, and that the 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.

Requirements:

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 pounds 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, resolving conflict, and overcoming resistance.

Social/Personal:

Commitment to objectives, maintaining successful team relationships, customer surveying, inspiring, influencing, and executing under pressure.

Methodical/Technical:

Presentations skills, development of successful project management process, project assessment, risk assessment, respect of budget, and timelines.