Full-Time Senior Statistical Programmer

Senior Statistical Programmer (SP) within the Ergomed Biostatistics (BS) department is responsible for creation of SDTM/ADaM datasets and programming tables, listings and figures or other types of output, supporting and complimenting the biostatistician(s) of a project and creating and maintaining appropriate documentation.

Senior Statistical Programmer is accountable for the first-time quality of the product, either dataset or output, via thorough QC steps.

Role and Responsibilities:

1. Maintains responsibility for all assigned duties within a clinical study, this may include:
2. Ensuring that work is performed on time
3. Ensuring all content created/reviewed is appropriate, valid, and relevant to the study and of high quality
4. Works with other biometrics’ team members to represent the needs and input of the programming components of the study
5. Program SDTM and ADaM datasets
6. Create SDTM and ADaM specifications
7. Create CDISC submission packages e.g. Define.xml and Reviewers Guide
8. Program tables, listings, and figures in SAS from specifications
9. Deliver training and mentorship to SP and other operational staff, as applicable
10. 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
11. Act as a statistical programming expert and provide consultative support to internal programmers and biostatisticians with any programming related topics
12. 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
13. Develop innovative techniques to solve complex programming problems on a clinical study or program of clinical studies to increase efficiency
14. Assist their manager with programming work projections to aid departmental planning
15. Represent statistical programming in client or agency study audits
16. Supports the Head of Biostatistics, or Manager/Director, Statistical Programming on topics related to programming issues, process improvement, industry trends, and other relevant topics

Education: Bachelor's Degree, preferably in Computer Science, Mathematics/Statistics, or a quantitative natural science.

Experience: 8 - 10 years’ of experience in developing derived datasets, TFL programming and submission packages in Clinical Research.

Skills: Organization skills, communication skills, PC skills, MS Office Suite, statistical programming languages (SAS, R), CDISC knowledge, P21E, SAS programming.

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