Time left to apply: End Date: October 21, 2024 (1 day left to apply)
Job Requisition ID: R2765151
* Location: Waterford
* Job Type: Fixed Term (23 months)
Purpose of the Role:
Provide stats guidance and direction across the MSAT DP network on approaches and continuous improvement plans.
Design, deploy and sustain best practices in statistical approaches/modelling and utilisation across MSAT DP network.
Participate and be lead input provider of DP MSAT on Global policy and procedure updates/forums to assure DP TT/NPI/LCM activity considerations are undertaken in same.
Participate in the development of site statistical systems, and rollout of support across the DP MSAT to upskill across the network.
Enable sites within the DP MSAT organisation in designing and deploying systems to transform data into useful process information.
Champion statistical best practices across the site and within the Sanofi MSAT DP network.
Provide oversight of the methods in which statistical expertise are applied to activities within the MSAT DP.
Job Requirements:
Provide statistical guidance for method validations and method transfers in the areas of accuracy, precision, linearity, equivalence testing (T OST), power and sample size.
Support major process engineering and/or quality investigations from a statistical perspective to ensure data is available to provide focused information as part of the problem-solving processes.
Develop the site's statistical process control (SPC) systems to help process engineers build a data-led understanding, including OCS/PCS, of the state of control of different manufacturing and laboratory processes.
Interface with site’s PCS team and site’s automation team to understand how data is captured and how available data relates to product and process critical process parameters.
Support the building of statistically based sampling plans in inspection areas.
Use the appropriate statistical tools for analysing many types of data problems.
Construct and apply various prediction (regression) equations including the application of statistical process control procedures.
Understand and deploy processes for data presentation (frequency tables, histograms and box plots), descriptive statistics, and statistical hypothesis testing.
Analyse and interpret statistical data to identify significant differences in relationships among sources of information.
Develop an understanding of fields to which statistical methods are to be applied.
Evaluate sources of information to determine any limitations in terms of reliability or usability.
Evaluate the statistical methods and procedures used to obtain data to ensure validity, applicability, efficiency, and accuracy.
Identify relationships and trends in data, and any factors that could affect the results of research.
Plan data collection methods for specific projects and determine the types and sizes of sample groups to be used.
Provide guidance on preparation of data for processing by organising information, checking for any inaccuracies, and adjusting and weighting the raw data.
Lead & provide guidance on reporting of results of statistical analyses.
Design research projects that apply valid scientific techniques.
Develop and test experimental designs, sampling techniques, and analytical methods.
Examine theories to discover mathematical bases for new or improved methods of obtaining and evaluating numerical data.
Establish and maintain internal/external network relationships in the area of statistics.
Qualifications:
* Bachelor's in Statistics, Biostatistics or Applied Maths with minimum 5 years prior work experience in Statistics OR
* Master's or PhD degree in Statistics, Biostatistics or Applied Maths.
Experience:
* 8+ years’ experience as a statistician, including a minimum of 3 years in a GMP regulated site.
Skills and Knowledge:
Excellent understanding of the applications of statistics in a manufacturing environment.
Excellent problem-solving and data analytical skills.
Experienced user of statistical analysis packages, particularly Minitab / JMP.
Strong influencing, communication and interpersonal skills, with experience working across multidisciplined and multicultural teams.
Flexible with the ability to prioritise work in a dynamic environment.
Familiar with regulatory statistical expectations.
Process understanding of the various stages of sterile manufacturing through to inspection and packaging.
Designation Duty:
* Site Statistical Lead and MSAT MT&I Manager as required.
Personal Characteristics:
High Energy and Commitment.
Ability to work independently.
Comfortable influencing across multiple stakeholders & department teams at international and corporate level.
Strong ability to coach and mentor others.
Effective Change agent and ability to manage resistance to change.
Capable of resolving issues of conflict effectively.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.
About Us
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com.
Why Sanofi
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
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