Job Description
Pay Rate: $90 - $100/Hour
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
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
Social/Personal :
Commitment to objectives, Maintaining successful team relationships, Customer survey, ability to inspire, influence and execute under pressure
Methodical / Technical
- Presentations skills, Development of successful project management process, Project assessment and risk
- assessment, Respect of budget and timelines
Certifications/Licenses:
Not Required.
Job Tags
Work at office, Local area,