JOB RESPONSIBILITIES:

• Contribute to statistical programming activities by developing or writing QC programs for statistical deliverables (SDTM/ADaM datasets, Tables, Listings and Figures) for statistical analysis.
• Contribute or occasionally design/lead program specifications and programming study documents.
• Lead portions of a project under the guidance of senior statistical programming staff members, including client facing activities, ensuring high quality, respecting project timelines and adherence to the budget. These may include individual parts of a study or individual studies in a multi-study project.
• Mentor junior statistical programming staff members on SAS techniques and clinical trial data with respect to CDISC standards and other regulatory requirements.
• Ensure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:
  1. clinical study reporting, e.g. ICH E3,
  2. electronic records handling, e.g. Chapter 21 of the US Code of Federal Regulation – Part 11,
  3. 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:

• 3 years of experience in biostatistics or statistical programming activities in the Pharmaceutical/Biotechnology industry in clinical development with good knowledge of SAS BASE, STAT, MACRO, SQL, Graph, of CDISC ADaM and SDTM, ICH Statistical and Clinical Report Guidelines
• Relevant experience with at least one TA and already exposed to the production/qc of SDTM / ADaM / ADaM’s like Datasets, Tables, Listings and Figures

Skills:

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