Senior Manager Programming (m/f/d)

Fresenius Kabi

  • Eysins, Vaud
  • CDI
  • Temps-plein
  • Il y a 18 jours
With our corporate philosophy of “caring for life”, we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology. Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland. As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.Fresenius Kabi SwissBiosim has also been certified as an Equal Pay Employer.Your assignmentsFunctional Goal:Sponsor accountable representative according to ICH and GCP principles in charge of the oversight of statistical programming activities outsourced to external partners. Provision of statistical programming expertise from clinical study set up to submission of clinical data packages to Regulatory Agencies. Accountability for technical acceptance of clinical data packages (in CDISC format or other required format) by Regulatory Agencies. Responsible for the programming or oversight of clinical outputs required to support Regulatory questions up to Regulatory approval and for outputs supporting Medical Affairs requests. Support to the development of internal programming processes and tools, including automation of specific tasks. Management of the clinical data repository and data analysis platform and other data exchanges tools. Accountability for Programming KPIs. Programming representative for Regulatory Inspections.Main Tasks:
  • Ensure completeness, correctness and consistency of clinical programming deliverables in all assigned clinical studies/programs to achieve high quality results in agreement with defined specifications and timelines;
  • Promote and propose standardization and automation of programming related tasks in collaboration with Biostatistics, Data Management and other clinical functions to improve consistency and efficiency of information management across biosimilars programs;
  • Maintain up to date advanced knowledge of programming software (e.g SAS) as well as industry requirements (e.g CDISC). Track emerging trends and apply them to improve programming support across all biosimilars programs;
  • Review CRFs/eCRFs and data management specifications documents; Statistical Analysis Plans/mock TLFs;
  • Lead data package preparation for electronic submissions. Review of CDISC packages (including, SDTMs and ADaMs datasets, define.xml, reviewer's guides, SAS programs...);
  • Subject Matter Expert for audits and inspections;
  • Participate in the selection process of CROs and provide oversight of outsourced activities;
  • Collaborate effectively with cross-functional teams and external partners;
  • Develop, review, update, and add relevant functional SOPs as company/situations evolve when applicable;
  • Management of functional tools for data storage, exchange and analysis.
Other Tasks:
  • Provide timely feedback and solutions to management regarding staffing needs;
  • Regular reports on status of programming deliverables quality/progress. Provide input for high level forecasting of timelines for programming tasks and estimation of resources and budget;
  • Interact proactively and in a solution orientated manner with other clinical and non-clinical functions.
Your profile
  • BSc or Master's degree in computer science, IT, statistics, mathematics or related field;
  • 8+ years of related industry experience within the functional area;
  • Thorough understanding of CDISC requirements, data standards principles and data formats accepted by different Health Authorities;
  • Advanced SAS experience and proven skills in the use of SAS within a statistical programming environment. Knowledge of other programming languages would be a plus;
  • Understanding of web based Electronic Data Capture and data management systems;
  • Experience with CRO oversight;
  • Ability to think beyond the home function, identifying connections between different areas of the organization to see the broader perspective;
  • Good knowledge of GxP environment, ICH and other relevant guidance documents (from FDA, EMA,…). Knowledge of computerized systems validation processes would be a plus;
  • Good communication skills in English; verbal, written, and presentation;
  • Highly motivated and enjoys working in a fast-paced environment;
  • Strong organizational skills and the ability to prioritize and multi-task;
  • Positive, flexible self-starter who thrives under pressure;
  • Fluency in English; German and/or French would be beneficial.

Fresenius Kabi