The Statistical Programmer I will conduct statistical programming activities for the reporting of clinical study data. The Statistical Programmer I will use programming techniques to produce SDTM and ADaM datasets, tables, listing and figures ensuring first-time quality, traceability and regulatory compliance.

JOB RESPONSIBILITIES:

• Contribute to statistical programming activities: Program and/or QC statistical deliverables (SDTM/ADaM datasets, Tables, Listings and Figures) for statistical analysis.
• Occasionally develop program specifications and design documents under supervision of Senior Statistical programmer.
• Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:
  • clinical study reporting, e.g. ICH E3,
  • electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation – Part 11,
  • electronic submission of clinical data to agencies, e.g. e-CTD guidance and CDISC SDTM and ADaM standards.
• Understand and follow all relevant standard operating procedures (SOPs).
• Keep abreast of current and new statistical programming techniques and other applicable technical advancements while assisting in their implementation
• Maintain up-to-date knowledge of programming software (e.g. SAS) as well as industry requirements (e.g. CDISC SDTM/ADaM, eCTD, Define.xml), attend functional meetings and trainings.

QUALIFICATIONS:  

Education:  BSc or equivalent with research experience, and/or MS (in a numerate discipline preferably in Statistics, Computer Science, or Mathematics). Master’s Degree preferred.

Experience:

• 1 year of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with knowledge of SAS BASE, STAT, MACRO, SQL, Graph, CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines.

Skills:

• Fluent in English with excellent organizational skills and good verbal and written communication skills.
• Ability to work effectively in international teams and to work independently is required.