Senior Statistical Programmer

Essential Duties and Responsibilities

• Acts as the Trial programmer on selected studies of moderate complexity, working directly with project team leaders and client representatives to assess and develop project goals and timelines. Assumes leadership responsibility as a contributing member of a multi-disciplinary clinical trials project team, communicating actively and frequently with other team members as needed.
• Independently creates, executes, maintains, and validates programs that transfer data across multiple data management systems or operating systems, combines data from a variety of sources and structures, generates and stores summary data from a variety of sources, generates reports or combines multiple databases and validates programs that generate listings, tables and figures using SAS.
• Manages and documents assignments to meet timelines and deliver high quality work, being familiar with any relevant contractual obligations or limits.
• Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry.
• Provides training and guidance to junior team members.
• Provides general infrastructure support to the department, including representing the company at industry conferences, presenting/teaching at department meetings, assisting in establishing training materials, and contributing to other general department documents or policies such as the development of departmental working practice documents and SOPs.
• Creation of specifications, development, validation, and delivery of CDISC SDTM and regulatory deliverables (eCRT Define.xml, SDTM aCRF).
• Analyzing and combining data from a variety of sources and structures including virtual trials, wearables, etc.
• Statistical safety reports (TLFs), safety event notifications and data alerts for study teams. 2
• Provide consult, analysis, and support across various therapeutic area studies in their CDISC compliance and consistency in mapping.
• Act as programming lead on Phase II-IV studies of simple to moderate complexity.
• As programming lead working directly with project team leaders and client representatives and where required to conduct team meetings, develop, and maintain project timelines, assess, and forecast resources, and monitor study budgets.

Job Qualification

• Bachelor or masters degree in Computer Science, Biostatistics, Statistics, Mathematics, or related field.

• 5+ years of experience working in clinical field (previous CRO experience is highly desirable).

• Solid SAS programming experience.

• End-to-end expertise in SDTMs/ADaMs and TLFs

• Strong understanding of relational data base structure and complex data systems.

• Project management or lead experience is desirable.

• Capable of providing mentorship and promoting teamwork in a multi-disciplinary team setting.

• Expertise in at least 2 therapeutic areas (including oncology)

• ISS/ISE/Submissions/RTQ's

• Familiarity with agile ways of working

• Fluency in English is essential