Statistician (Non-clinical) - Global

  • Salary: Competitive
  • REF Number: 00041536
  • Consultant: Stephanie Maccioni
  • Contact: 01438 768713
  • Date Published: 23.03.2018
  • Closed Date: 15.05.2018
  • Sector: Non-Specific
  • Location: Belgium, Israel, USA
  • Discipline: Statistics And Programming

Stephanie Maccioni is engaging in a huge project with a global Pharmaceutical company to appoint multiple Non-clinical Statisticians. This role is offering site work across multiple locations all over the world, or remote work if preferred as well as contract or permanent employment depending on your preference. In return they are looking for talented professionals to join them on a global scale. In addition to this, our client will offer sponsorship and support with relocation depending on your circumstances.

Main duties and responsibilities:

  • Develop Statistical Capability Strategy for Operations, collaborating with R&D as needed as part to ensure alignment along the product life cycle
  • Provide statistical subject matter expertise, leadership and guidance to site-based teams collaborating with Opex, MS&T, Production, Quality, Engineering to build know-how and understanding how to use data to drive value.
  • Build statistical capability within Site Operations and collaborate with Process Robustness lead to remediate the robustness related issues (process and analytical) to positively impact product quality, yield and cost.
  • Provide statistical training & support to ensure Continuous Process Verification (CPV) for commercial product portfolio is being performed in line with policy and procedures to assure a state of control per requirements of CPV.
  • Collaborate with MS&T TGO to further develop and align best practices in data analytics to support deeper understanding of the API influence in drug product processing.
  • Collaborate with Knowledge Management Head to ensure process data & analytics is captured and facilitate sharing of best practices and lessons learned
  • Collaborate with CMC partners to support a culture of risk based decision making, based on data and scientific justification.
  • Identify, create and maintain guidelines and training procedure(s) for statistical know-how and keep abreast of advances in industry on data capture & analytics to drive value

Key Requirements:

  • M.A. degree in statistics, mathematics or equivalent science degree
  • Extensive knowledge and practical experience of Pharmaceutical (API and or Drug Product) R&D and manufacturing operations
  • Extensive experience in applied statistics and use of statistical software tools
  • Experience in designing, executing and analysing DOE studies.
  • Knowledge and experience in implementation of statistical process control (SPC)
  • Knowledgeable in knowledge and risk management processes and systems.
  • Knowledge of regulatory requirements related to pharmaceutical development and manufacturing.
  • Experience with interactions with regulatory agencies.
  • M.A. degree in statistics, mathematics or equivalent science degree
  • Extensive knowledge and practical experience of Pharmaceutical (API and or Drug Product) R&D and manufacturing operations
  • Extensive experience in applied statistics and use of statistical software tools

A full job spec is available upon request

For more information or to apply for this position, please contact Stephanie Maccioni on 01438 768713 or email smaccioni@ckclinical.co.uk. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL41536 in all correspondence.

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