Summary of Major Responsibilities
The Statistical Process Control Statistician will support the commercial analytical lab (AL), which performs various ODx assays, and monitor and conduct surveillance of the assay processes, generally using statistical process control (SPC). This role will use a familiarity with Tableau and experience with data trending using regression techniques. This role will also engage in AL support activities; including, but not limited to, the development of reagent pools, search data for appropriate characteristics, design, and analysis of stability studies, and troubleshoot AL anomalous observations.Essential Duties and Responsibilities
- Provide SPC-mediated support of the AL.
- Engage in stability study design and data analysis.
- Study design and analytical methods resources for the AL.
- Collaborate with colleagues in the AL and train AL personnel in process monitoring practices.
- Work on cross-functional teams to achieve longer term process improvement goals.
- Prepare and present presentations for intra- and inter-departmental meetings.
- Monitor and conduct surveillance of assay processes, using SPC.
- Examine data trending through the use of regression techniques.
- Design and analysis of stability studies and troubleshoot AL anomalous observations.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company's Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to work seated for approximately 90% of a typical working day. Ability to work standing for approximately 10% of a typical working day.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to travel 5% of working time away from work location, may include overnight/weekend travel.
- Bachelor's Degree in Statistics, Applied Statistics, or related field as outlined in the essential duties.
- 5+ years of experience working in a biotech or pharma commercial laboratory.
- Demonstrated ability to set acceptance criteria and specification and alert limits.
- Demonstrated ability to use basic descriptive and inferential statistical techniques; including, but not limited to, linear regression, and the use of interval confidence and tolerance estimation.
- Proficient in statistical process control.
- Proficient in data trending using regression.
- Proficient in Microsoft Office programs.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Authorization to work in the United States without sponsorship.
- Experience using Tableau software.
- Experience with SAS, JMP, R, and/or Python.
- Experience with Excel Macros.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.