Katalyst Healthcares & Life Sciences is hiring: SENIOR STATISTICIAN (MANUFACTURI

Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description Job Summary: We are a reagent manufacturing site looking for an Applied Statistician with industry experience. The candidate should have experience analyzing process-based data and writing up findings accordingly. There will be a focus on process control and process capability assessments. Our statistician does not participate extensively in pFMEA assessments, rather just as support when needed. SAS and R programming are also not pre-requisites. Minitab and/or JMP software are the stats programs used predominantly here. We are not seeking anyone with a clinical background. We are seeking candidates with a process background (Manufacturing process background). The ideal candidate will have a background in Science. This person will be validating the processes to formulate and fill the reagents. Responsibilities: Responsible for collection, analysis, interpretation, processing and presentation of numerical information relative to process validation in a cGMP /CBER regulated medical device manufacturing environment. Provides statistical analyses in comprehensive written reports or sampling plans, as appropriate. Leads or participates in process FMEA and implementation and validation of appropriate process controls. Generates and analyzes control charts to identify irregularities and errors. Leads or participates in the development and implementation of statistical models and sampling plans for application in validation. Coordinates meetings to resolve issues. Generates and analyzes control charts as part of periodic trend analysis and develops statistical reports with data interpretation as part of the validation lifecycle (validation, monitoring, and revalidation). Makes recommendations, and when appropriate, acts independently to resolve scientific problems encountered during experimental procedures to improve productivity of results. Ensures activities are consistent with project critical path, and responds appropriately to changing priorities or schedules. Serves as a statistical analysis subject matter expert for assigned projects. Must be able to communicate statistical approach and analysis in an understandable manner to people with little or no knowledge of statistics. Qualifications: Education: Bachelor’s degree or Master’s degree in statistics, or equivalent combination of education and work-related experience, required. Master’s degree, in math, statistics or engineering. Job-related Experience: Minimum (required): 2 years related experience in medical device, Biotech or pharmaceutical industry, including control process charting and application of statistical sampling plans. Preferred: 5 years of relevant work experience. Other qualifications: Knowledge and experience in IVD, Pharmaceutical, and or Medical Device Industry; Industry Standards for Validation; Industrial Statistics, Federal cGMPs and QSRs, ISO 13485. Expert understanding of process FMEA, control charting and statistical process controls with a keen ability for identifying irregularities and errors. Must be able to communicate statistical approach and analysis in an understandable manner to people with little or no knowledge of statistics. Excellent written and verbal communication skills with ability to multi-task are required. SKILLS AND CERTIFICATIONS Continued process verification (CPV) Minitab and/or JMP Additional Information All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr