Senior Manager Programming (m/f/d), Eysins

Fresenius Kabi ist ein weltweit tätiges Gesundheitsunternehmen, das Medikamente und Medizinprodukte zur Infusion, Transfusion und klinischen Ernährung anbietet. Unsere Produkte und Dienstleistungen werden in der Therapie und Versorgung von kritisch und chronisch kranken Patienten eingesetzt.

Your assignments

Functional Goal:

• Sponsor accountable representative according to ICH and GCP principles to assure the oversight of 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 and responsibility for technical acceptance of CDISC packages by Regulatory Agencies
• Responsible for the programming or oversight of outputs required to support Regulatory questions up to Regulatory approval
• Support to the development of internal programming processes and tools, including automation of specific tasks
• Management of the functional internal 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 and other departments to improve consistency and efficiency of information management across all 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 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 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 solution orientated 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 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
• Knowledge 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