Senior Manager Statistical Programming
A global healthcare company is advertising a vacancy for a Senior Manager Statistical Programming at their office in Switzerland. The organisation specialises in lifesaving medicines and technologies for infusion, transfusion, and clinical nutrition. The company's products and services have been used to help care for critically and chronically ill patients. This is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- Leading and overseeing data package preparation for electronic submissions.
- Reviewing of CDISC packages (including, SDTMs and ADaMs datasets, define.xml, reviewer's guides, SAS programs) and assuring FDA, EMA compliance.
- Ensuring according to GCP/ICH as sponsor representative and accountable person completeness, correctness and consistency of clinical and non-clinical programming deliverables in all assigned clinical studies/programs to achieve high-quality results in agreement with defined specifications and timelines.
- Ensuring accurate and timely sponsor responses to questions during dossier review by defining, leading and quality checking the programming requirement related to this at the vendor.
- Managing the specialised, validated platform hosting transferred propriety data packages from vendors and ensuring maintenance and quality outputs.
- Promoting and proposing standardization and automation of programming related tasks in collaboration with Biostatistics and other departments to improve the consistency and efficiency of information management across all biosimilars programs.
- Maintaining 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.
- Reviewing CRFs/eCRFs and data management specifications documents and Statistical Analysis Plans/mock TLFs.
- Sponsoring Subject Matter Expert for audits and inspections.
- Participating in the selection process of CROs and provide oversight of outsourced activities.
- Collaborating effectively with cross-functional teams and external partners.
- Developing, reviewing, updating and add SOPs as company/situations evolve when applicable.
Skills and Requirements:
- BSc or Master's degree in computer science, IT, statistics, mathematics or related field.
- 8+ years of related industry experience within the functional area.
- Provide timely feedback and solutions to management regarding staffing needs.
- Regular reports on the status of programming deliverables quality/progress.
- Providin input for high-level forecasting of timelines for programming tasks and estimation of resources and budget.
- Interacting proactively and being solution orientated with other clinical and non-clinical functions.
- 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 and EMA).
- Knowledge of computerised systems validation processes would be a plus.
- Highly motivated and enjoys working in a fast-paced environment.
- Positive, flexible self-starter who thrives under pressure.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Heidi Hennigan at 0203 854 1033 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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