Statistician IV

Job Description

Job Summary:

• 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.

Responsibilities:

• Under limited supervision and in accordance with all applicable federal, state and local laws/regulations, the Companies’ policies, procedures and guidelines.
• 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 skill set 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 – 3 – IV.

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
• Social/Personal : Commitment to objectives, Maintaining successful team relationships, Customer survey, ability to inspire, influence and execute under pressure
• Methodical / Technical o Presentations skills, Development of successful project management process, Project assessment and risk assessment, Respect of budget and timelines