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We have a clear commitment: putting best-possible solutions in the hands of medical professionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations.
#careerswithapurpose at Fresenius
Over 300,000 people across the globe work at Fresenius to provide better ever medicine for ever more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
Job Summary
We have a clear commitment: putting best-possible solutions in the hands of medical professionals, enabling them to find the right answer to the challenge they face. Fresenius Kabi is a driver of healthcare for the coming decade. We truly live diversity and value different backgrounds and motivations.
#careerswithapurpose at Fresenius
Over 300,000 people across the globe work at Fresenius to provide better ever medicine for ever more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
Job Summary
Functional Goal:
Sponsor accountable representative according to ICH and GCP principles in charge of statistical programming activities, including when 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;
* Design, implement and validate SAS programs for data manipulation and statistical analysis;
* Review and provide input on Statistical Analysis Plans (SAPs), including programming methodologies and documentation;
* 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;
* Manage 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;
* Mentor and train junior programming staff, fostering a culture of continuous learning and improvement.
Qualification profile:
* B.Sc. 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. Experience with submissions to Regulatory Agencies, including FDA;
* Advanced SAS proficiency and proven skills in the use of SAS within a statistical programming environment. Knowledge of other programming languages (e.g. R) would be a plus;
* Experience with data visualization tools and techniques;
* Solid understanding of statistical concepts and methodologies used in clinical research;
* Understanding of 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 and ability to work collaboratively in an international environment;
* Highly motivated and enjoys working in a fast-paced environment;
* Strong organizational skills and the ability to prioritize and multitask;
* Positive, flexible self-starter who thrives under pressure;
* Fluency in English.
Your contact
Elisa Arnaud
Fresenius Kabi SwissBioSim GmbH
Eysins
Kennziffer R-10007407
karriere.fresenius.de/en-US/
fresenius.com
fresenius-kabi.com
We welcome diversity
At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics. All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse).
All references to persons in this job advertisement apply equally to all genders (male, female, diverse).
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Information Technology
* Industries
Health and Human Services
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