Position Details
Quality System Specialist Statistics Apply
Job Title: Quality - Quality System Specialist
Expected Start/End Dates: 11/18/2024 - 11/17/2025
Worker Location: Holly Springs, NC 27540
Length of Assignment: 12 months (Possible extension for long term)
Shift/Schedule Details: Standard business hours with some flexibility to work early mornings/evenings to accommodate global meetings (as needed)
Also, required to be present onsite 50% of the time, this can be flexible as long as requirement is met.
Worker Location: Holly Springs, NC 27540
Length of Assignment: 12 months (Possible extension for long term)
Shift/Schedule Details: Standard business hours with some flexibility to work early mornings/evenings to accommodate global meetings (as needed)
Also, required to be present onsite 50% of the time, this can be flexible as long as requirement is met.
Job Description:
- Provide technical statistical expertise, leadership and guidance to facilitate ongoing development and growth of Statistics to support projects aligned with strategic objectives
- Assumes responsibility for methodological and statistical aspects of projects by ensuring strong statistical foundation underpins project strategy and provides sound strategic, statistical and scientific input on program objectives, experimental design, and data analysis to meet regulatory and scientific requirements.
- Conducts statistical analyses of testing results and process anomalies
- Writes, reviews, approves and/or executes documentation for new and current technical reports related to products and/or processes
- Maintain comprehensive knowledge and awareness of developments and trends in theoretical and applied Statistical theory and Regulatory developments, in relation to the statistical methodology applicable in a non-clinical setting.
- Development and application of new and novel statistical techniques that are effective, efficient and supporting innovation and efficiencies to projects,
- Provides training and guidance on the application of basic statistical methodology by staff across Quality.
Minimum Required Qualifications:
- Bachelor's degree in Statistics, Biostatistics, Mathematics, or a related field (Master's degree preferred).
- Minimum 5 years' experience in statistical analysis and methodology, preferably in a non-clinical setting (additional experience will be required for mid to senior level candidates).
- Proficiency in statistical software (e.g. SAS, R, Python).
- Familiarity with regulatory requirements and guidelines related to statistical methods in non-clinical settings.
- Good interpersonal skills
- Comfortable with articulating statistical concepts to non-statisticians
Interview Process will look like:
- 1-2 rounds of interviews lasting no longer than 45 minutes to an hour
- Interviews will be conducted remote, with at least one of the interviews occurring in the evening to accommodate APAC time zone as one of the interviewers is based in Australia
- No more than 1-2 people will sit in on the interview.
