Senior Principal SDTM Programmer (m/w/d).

Job ID: 11652

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Type of employment
Project Consulting

The Senior Principal SDTM (Study Data Tabulation Model) Programmer is responsible for overseeing all SDTM programming aspects of various studies (including both images and conversions) at the project level (including submissions and post-marketing activities). This is a role as a key contributor and strategic partner with additional role in ensuring that the drug development plans are executed with effective, on-time, and high quality results by the ESP (External Service Provider).

  • Oversight (and support governance) of the ESP in-house SDTM programming deliverables, data provisioning activities to ensure the on time and qualitative creation and validation of SDTM datasets, submissions, approvals and Health Authority interactions
  • SDTM decision making and strategy recommendation for studies
  • Provide SDTM programming advice, expertise and input into SDTM process development
  • Establish and maintain an effective working relationship with cross-functional teams and ESP partners when working on individual studies in accordance with the agreed contract and internal business guidelines. Has the ability to summarize the status of results and critical programming aspects/requirements (schedule, scope) and to discuss these with the internal and/or ESP study team
  • Review of eCRF (electronic Case Report Form) and other ESP deliverables e.g. SDTM and raw data, ensuring the incorporation of industry standards (e.g. CDISC – Clinical Data Interchange Standards Consortium) and standardization at the partnership level that enables pooling and effective submission package production.
  • BA/BS/MS or internationally equivalent experience in statistics, computer science, mathematics, life sciences or comparable training
  • Languages: Fluent in English (verbal and written)
  • Extensive experience in participating in Statistical Analysis Plans and/or the creation of technical programming specifications
  • Relevant SAS experience and demonstrated skills using SAS within the statistical programming environment to produce and validate results; proven experience in developing advanced macros
  • Deep understanding of industry standards with CDISC data structures and a solid understanding in the development and use of standard programs
  • Excellent knowledge of submission related activities
  • Good understanding or regulatory requirements that are relevant with regards to Statistical Programming (e.g. GCP, study procedures)
  • Proven communication and negotiation skills, the ability to work well and influence others on a global scale
  • Experience as Lead/Project programmer in several studies or activities at a Program level, including coordinating a team of internal or external programmers for a specific study or program; the ability to pass on one’s own knowledge to others
  • Ideally 9+ years of professional experience as a programmer, preferably supporting clinical studies or in the pharmaceutical industry