Manager Statistical Programming - Oncology
- Permanent
- Programming
- United Kingdom
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Proclinical is seeking a dedicated and detail-oriented Manager for Statistical Programming. This role involves working collaboratively with the Clinical Development team or CRO to meet project deliverables and timelines for statistical data analysis and reporting. The successful candidate will also contribute to the development of a global programming standard library and provide functional expertise in the development and implementation of the company's centralised clinical data repository.
Responsibilities:
- Work alongside the Clinical Development teams to ensure timelines are met for project deliverables.
- Independently perform and oversee the production and validation of programming deliverables.
- Anticipate resource needs and work with management to ensure adequate long-term resource allocation within a therapeutic project.
- Ensure quality control is performed on all process and technical activities related to derived dataset, table, listing, and figure programming.
- Participate in the development of a global programming standard library.
- Provide functional expertise in the development and implementation of our centralized clinical data repository, clinical data dictionary, and operational data dictionary.
- Collaborate with Biostatistics to develop, implement and maintain appropriate statistical applications.
- Provide programming support to regulatory submissions including data submission package and define.xml development.
Key Skills and Requirements:
- BSc in Statistics, Mathematics, Computer Science, or related discipline. Advanced degree is a plus.
- Experience in a pharmaceutical industry, CRO or another clinical research setting.
- Strong competence in statistical programming including SAS/Base, Macro, STAT, GRAPH, SQL, etc.
- Good understanding of FDA, EMA, ICH, and global regulations and guidelines.
- Solid knowledge and experience of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards.
- Experience in Oncology or Infectious Disease therapeutic areas and submission is preferred.
- Project management experience, detail-oriented, and strong organizational and communication skills in English.
- Ability to work in a fast-paced, dynamic team environment as well as strong analytical and problem-solving skills.
If you are having difficulty in applying or if you have any questions, please contact Heidi Hennigan on h.hennigan@proclinical.com.
Apply Now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.