Instagram
youtube
Facebook

Senior Statistician (Manufacturing)

2+ years
Not Disclosed
10 Nov. 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Company Description

Katalyst Healthcares & Life Sciences is hiring entry-level candidates for various positions in contract research related to clinical trials of drugs, biologics, and medical devices. Immediate opportunities are available in Drug Safety, Pharmacovigilance, and Clinical Research. We collaborate with university hospitals, pharmaceutical companies, and recruitment partners to advance healthcare solutions.


Job Description

Position: Applied Statistician

Join our reagent manufacturing site as an Applied Statistician, specializing in process-based data analysis and validation in a cGMP/CBER-regulated environment. This role focuses on process control and process capability assessments, with minimal involvement in pFMEA assessments. Expertise in Minitab and/or JMP software is preferred, while SAS and R programming are not required. A manufacturing process background is essential.


Key Responsibilities

  • Collect, analyze, interpret, and present numerical data related to process validation in a regulated medical device manufacturing environment.
  • Provide comprehensive statistical analyses, written reports, and sampling plans.
  • Lead or support process FMEA assessments and validate appropriate process controls.
  • Generate and analyze control charts to detect irregularities and recommend corrective actions.
  • Develop and implement statistical models and sampling plans for validation lifecycle activities, including monitoring and revalidation.
  • Prepare periodic trend analyses and statistical reports with data interpretation.
  • Propose solutions to scientific challenges during experimental procedures, ensuring alignment with project priorities and timelines.
  • Serve as a statistical subject matter expert (SME) for assigned projects.
  • Communicate statistical methods and findings clearly to non-statistical audiences.

Qualifications

Education

  • Bachelor’s or Master’s degree in Statistics, Mathematics, or Engineering.

Experience

  • Required:
    • Minimum 2 years of relevant experience in the medical device, biotech, or pharmaceutical industry, including control process charting and statistical sampling plans.
  • Preferred:
    • 5+ years of related work experience.

Skills and Knowledge

  • Expertise in IVD, pharmaceutical, or medical device industry standards, including validation, statistical process controls, and industrial statistics.
  • Proficiency in Minitab and/or JMP software.
  • Strong understanding of process FMEA, control charting, and error identification.
  • Ability to communicate statistical concepts to non-technical stakeholders effectively.
  • Excellent written and verbal communication skills.

Additional Information

All information will be kept confidential as per EEO guidelines.