Senior Manager Programming (m/f/d)

Fresenius SE & Co. KGaA; Eysins; Vor Ort; CHF 90’000 - 120’000; Vollzeit

Zusammenfassung

A leading international company is seeking a Sponsor accountable representative to oversee statistical programming activities, ensuring high quality deliverables in compliance with ICH and GCP principles. The role involves managing clinical outputs for regulatory submissions and requires extensive experience and expertise in statistical programming, specifically with SAS.

Qualifikationen

• 8+ years of related industry experience.
• Thorough understanding of CDISC requirements and regulatory submissions.
• Good knowledge of GxP environment and ICH guidelines.

Aufgaben

• Ensure quality of clinical programming deliverables.
• Design, implement and validate SAS programs.
• Lead data package preparation for electronic submissions.

Kenntnisse

SAS proficiency

Statistical concepts

Programming languages (R)

Data visualization techniques

Communication skills

Ausbildung

BSc or Master’s degree in Computer Science, IT, Statistics, Mathematics

Jobbeschreibung

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:

• 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. 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 multi-task;

• Positive, flexible self-starter who thrives under pressure;

• Fluency in English.