Senior Statistical Programmer

Summary

Join Ergomed Group, a rapidly expanding CRO specializing in Oncology and Rare Disease, as a Senior Statistical Programmer. You will be responsible for creating SDTM/ADaM datasets and programming tables, listings, and figures. This role requires extensive SAS programming knowledge, advanced CDISC knowledge, and a minimum of 10 years of experience in clinical research. You will collaborate with biostatisticians, mentor junior staff, and contribute to process improvement. Ergomed offers a supportive work environment, career development opportunities, and a chance to work with a global team.

Requirements

• Bachelor's Degree, preferably in Computer Science, Mathematics/Statistics, or a quantitative natural science
• Extensive knowledge of SAS programming and statistical programming topics relevant to clinical trials including statistical analysis-based procedures and/or indication specific methods; may have expertise in one or more topics
• Advanced CDISC knowledge
• Hands-on experience using P21E
• Minimum of 10 years’ of experience in developing derived datasets, TFL programming and submission packages in Clinical Research
• Organization skills, including attention to detail and multitasking
• Communication skills
• PC Skills
• Knowledge of the MS Office Suite
• Proficiency in one or more statistical programming languages (includes SAS, R)

Responsibilities

• Maintain responsibility for all assigned duties within a clinical study, this may include: Ensuring that work is performed on time
• Ensure all content created/reviewed is appropriate, valid, and relevant to the study and of high quality
• Work with other biometrics’ team members to represent the needs and input of the programming components of the study
• Program SDTM and ADaM datasets
• Create SDTM and ADaM specifications
• Create CDISC submission packages e.g. Define.xml and Reviewers Guide
• Program tables, listings, and figures in SAS from specifications
• Deliver training and mentorship to SP and other operational staff, as applicable
• Contribute to the development of the department in supporting adherence to good programming and best practices by contributing to training, development of macros and standard processes, input and/or review of controlled documents, or other related content
• Act as a statistical programming expert and provide consultative support to internal programmers and biostatisticians with any programming related topics
• Act as a program or sponsor lead across multiple studies, clinical programs, and/or large complex studies with responsibility for all statistical programming activities and ensuring consistency across multiple studies
• Develop innovative techniques to solve complex programming problems on a clinical study or program of clinical studies to increase efficiency
• Assist their manager with programming work projections to aid departmental planning
• Represent statistical programming in client or agency study audits
• Support the Head of Biostatistics, or Manager/Director, Statistical Programming on topics related to programming issues, process improvement, industry trends, and other relevant topics

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language