Reference No. R2771083

Position Title: Manager, Biostatistics- Vaccines

Department: Biostatistics

Location: Toronto, ON

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

Under the general direction of the Deputy Director of Biostatistics, the Manager Biostatistics provides analysis of data, interpretation of data analysis within Quality and Manufacturing & Supply, in all areas of vaccine testing, stability, production, and analytical sciences. The key statistical activities include experimental design, power and sample size calculation, statistical analysis of data to support development, improvement or modifications and validation of test methods, comparability studies, out of specification calculation, setting limits for reference standards and controls, setting product release and stability limits, control charts, developing statistical analysis to support investigations, addressing questions from regulatory agencies, trending, stability assessments, and other statistical needs. Other activities may include performing statistical analysis of stability program results to identify changes in product stability trends, and identification of OOT results.

• Responsible for providing statistical services of assigned projects to ensure objectives are met, and providing timely delivery and quality of analyses and reports.
  
• Author and review statistical analyses, reports and applicable written communication of results, and communicate relevant findings and conclusions effectively. Provide statistical consultation to Quality functions, contract statistical services and other functions at Sanofi.
  
• Support laboratory studies (e.g., validation, comparability, qualification, limit setting, stability, feasibility, development, robustness, trending, design of experiment), investigations and regulatory questions through application of appropriate statistical analysis and provide appropriate interpretation of results.
  
• Develop and/or verify existing calculation programs according to Standard Operating Procedures and calculations with license agreement and current regulations. Develop, validate, update, and maintain tools used for statistical calculations, data analysis and trending.
  
• Keep abreast of statistical literature and maintain current knowledge of industry standards and relevant scientific disciplines to ensure current developments are implemented when appropriate.
  
• Provide training to new members and scientific staff, and consultation on statistical matters.
  

• Provide support and consultation on study design, data requirements, experimental design, response to regulatory questions, with wide range of stake holders involved in joint projects, from technologists, scientists, managers, and directors of Quality to staff in regulatory affairs, regulatory agencies or statisticians at other departments and sites.
  
• Use sound and advanced statistical methodologies, perform analyses and interpretation of data in the assigned projects, write statistical analysis method and design, perform sample size calculation, data management, statistical analyses, write clear statistical report of the data analysis results, and communicate statistical results and conclusions effectively to project team.
  
• Perform review of statistical analysis and reports completed by peers.
  
• Provide consultation in the duration of project from planning to final reporting. Perform review of study protocols and reports.
  
• Present and share results with project team at team meetings. Participate and represent the department at relevant project meetings.
  
• Strong Team player. Quality service and cooperation are essential to the success of projects for which statistical input is required. Thus, commitment to the needs and goals of the team is a vital aspect of the role.
  

• Statistical training and experience equivalent to a Master or Ph.D degree in statistics or biostatistics, and preferably with science courses.
  
• Experience working as a statistician or statistical consultant (or equivalent) for a period of three or more years, preferably in pre-clinical development statistics.
  
• A strong practical experience in R and SAS statistical programming, and interpretation of statistical results, including use of a variety of statistical methods and models (e.g., linear and non-linear models, non-parametric analysis, mixed effect model, categorical data analysis, equivalence test, stability trending, sample size calculation).
  
• Experience with other analytical tools (e.g., Python, JMP) and programming language would be a strong asset.
  
• A good working knowledge of Microsoft Office applications such as Word, Excel, Powerpoint.
  
• Strong written and oral communication skills. Ability to effectively communicate statistical concepts.
  
• Strong attention and accuracy with details. Commitment to quality.
  
• Strong team player. Strong working relationships and effective interpersonal interaction skills.
  
• Ability to effectively manage multiple tasks and projects.
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs