The Senior Statistical Programmer provides statistical software programming solutions and their documentation to Biostatistics in general and to support analysis and reporting of clinical trial and/or project data for regulatory submission. She/he supports the Project Programmer in designing and implementing the statistical programming strategy on a project. The Senior Statistical Programmer coordinates and performs statistical programming activities such that agreed objectives, standards, deadlines and other requirements with respect to specifications, program development, quality assurance and report delivery are attained in accordance with applicable processes.
Primary Responsibilities and Accountabilities
- Provide advice and support to the statistical team on programming activities related to analysis and reporting of assigned drug development study/project results. Assess and clarify requirements, provide statistical programming solutions and ensure their efficient implementation.
- Contribute to CRF development and data structures definitions for clinical trials. Ensure consistency and adherence to available standards.
- Ensure that user acceptance testing on the structure and quality of data provided by Data Management is performed. As appropriate, perform the user acceptance testing of data structure and execute data quality acceptance checks. Develop additional study-specific checks as required.
- Develop programming specifications and ensures consistency with the statistical specifications for analysis datasets (VADs), pooled datasets, listings, tables, and figures.
- Plan and perform programming, validation and documentation activities for VADs, pooled datasets, listings, tables, and figures according to specifications, with high quality and within agreed time lines.
- Ensure adherence to statistical programming standards, effective use of available standard programs and compliance with Standard Operating Procedures.
- Support regulatory submission specific activities, e.g. electronic submission creation.
- Maintain efficient interfaces with internal and external customers.
- University education (BSc or MSc) or equivalent in Statistics, Computer Science, Mathematics or other analytical field.
- Very strong knowledge of SAS programming language with SAS/Base, SAS Macro, SAS/Graph, SAS SQL and some SAS/STATS
- Good knowledge of English in a business environment
Experience, Skills, Knowledge:
- Strong SAS experience within a Clinical/Pharmaceutical environment
- Good knowledge of drug development process in particular on collection, storing, processing and analysis of clinical trial data.
- Has well developed planning and analytic abilities.
- Communicates clearly and effectively in written and oral form.
- Experience with Clinical Outcomes/Patient Reported Outcomes (Questionnaire) data types is favorable but not essential.
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email email@example.com