Janssen Supply Group, LLC is recruiting for a Principal Bayesian Statistician, Advanced Analytics (AA) & Design to Value (DtV). The preferred location for this position is in Raritan, NJ but considerations will also be made for the following sites: Titusville, NJ; Spring House, PA; Malvern, PA; Horsham, PA; Beerse, Belgium; or Schaffhausen, Switzerland.
Janssen Supply Group, LLC is part of Janssen Supply Chain, a global organization responsible for supplying medicines to markets around the world. With Quality as their primary focus, this group strives to provides access and affordability through innovation and strong collaboration with their R&D and Commercial partners to deliver life changing solutions for patients in need.
The Product Quality Management (PQM) Advanced Analytics (AA) & Design to Value (DtV) Principal Bayesian Statistician is responsible for leading AA & DtV systems improvement throughout the Global Pharma Quality organization, including device, drug and combination products. He or she will develop and apply methods and systems to incorporate Science, Risk, Knowledge and data into organizational decisions made throughout Pharmaceutical Development and Manufacturing Science (PDMS) and Janssen Supply Chain (JSC). The incumbent will perform the following activities: development of Bayesian methods for Informed Decision Making, benchmarking, deployment of projects related to cost and quality, and approval as well as execution of statistical analyses.
The Principal Bayesian Statistician, (Advanced Analytics & Design to Value) will:
- Work with global functions and sites to develop and deploy Informed Decision Making methods and systems (Bayesian and Frequentist).
- Provide direction in the use of applied statistics for the Global Pharma Quality organization.
- Represent the Global Pharma Quality organization as a Subject Matter Expert for Bayesian statistical analysis.
- Ensure standard Informed Decision Making processes and norms are implemented across: functions, sites, and facilities.
- Assist with Pharma and Combination product related regulatory visits, corporate audits and vendor audits and also provide follow up on regulatory commitments.
- Develop and deliver training for statistical methods (virtual and in person).
- Provide support to JSC in defining, collecting, and analyzing Quality Metrics such as Best Practices, Design to Value progress metrics and Implementation of dashboard tools.
- Apply intensive and diversified knowledge of Bayesian statistics to broad areas of the Janssen Supply Chain decision making processes including; DtV, AA, Design Controls, Process Validation and Supplier Management.
- Plan, develop, coordinate, and direct global initiatives as well as a number of sub-projects with many complex features.
- Contribute to the development of new or improved statistical techniques or procedures related to the statistical tools and business processes used within JSC.
- Train and mentor JSC employees in Bayesian methods and Informed Decision Making.
- Develop and evaluate plans and criteria for a variety of projects and activities to be carried out by others.
- A combination of the following education and experience is required: A PhD in Statistics with a minimum of 5 years related experience OR a Master’s degree in Statistics with a minimum of 7 years related experience.
- A Graduate degree in Bayesian statistics is highly preferred.
- Experience in a regulated industry is required.
- Knowledge of Bayesian and Frequentist methods required
- Excellent technical writing skills; experienced in SOPs, protocols, reports highly preferred.
- Project management training or experience is highly preferred.
- A background in engineering preferred.
- Knowledge of Biotech and/or Pharma Manufacturing is preferred.
- Experience in technology transfer/design transfer is preferred.
- Knowledge and experience deploying Bayesian methods in development and manufacturing is preferred.
- Six Sigma Master Black Belt or Black belt certification is preferred.
- Experience with Quality Systems, cGMP, and ICH Requirements preferred.
- Knowledge of QbD (Quality by Design), basic manufacturing processes, LEAN, basic automation/IT/lab systems development (i.e., design of experiments) and test processes preferred.
- The preferred location for this position is in Raritan, NJ but considerations will also be made for the following sites: Titusville, NJ; Spring House, PA; Malvern, PA; Horsham, PA; Beerse, Belgium; or Schaffhausen, Switzerland.
- This position may also require up to 25% domestic and international travel.
United States-New Jersey-RaritanOther Locations
Europe/Middle East/Africa-Switzerland-Schaffhausen-Schaffhausen, North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Malvern, North America-United States-Pennsylvania-Horsham, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization
JANSSEN SUPPLY GROUP, LLC (6046)Job Function
Quality (Eng)Requisition ID