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Manager, Statistical Programming (SDTM)

Manager, Statistical Programming (SDTM)

SEC Life SciencesCanada
30+ days ago
Job type
  • Permanent
Job description

With over 120 years of experience and a large workforce spanning 20+ countries, this company is dedicated to pioneering medical advancements that enhance the quality of life globally. Their EU operations are focused on two critical areas : cardiovascular health and oncology.

The company aims to protect individuals from cardiovascular diseases, the leading cause of death in Europe, while the Oncology division strives to innovate and develop new therapies for cancer patients.

The firm has offices in 13 European countries as well as a Canadian affiliate, and they are now seeking a highly qualified candidate for the position of Manager, Statistical Programming for SDTM.

This position can be worked remotely, and the company is open to considering applicants in Germany, Switzerland, UK, Austria and Canada. This role offers the opportunity to be part of a dynamic team that is instrumental in advancing their oncology pipeline and expediting regulatory submissions.

Your Role as Manager, Statistical Programming for SDTM

  • Lead the programmatic generation of statistical deliverables to ensure quality for pivotal studies and regulatory submissions.
  • Generate and review Case Report Form (CRF) annotations and Study Data Tabulation Model (SDTM) datasets.
  • Oversee statistical programming vendors to ensure high-quality deliverables and adherence to project timelines.
  • Maintain institutional knowledge across oncology compounds to support the development of standard programming practices.
  • Provide programming support for regulatory submissions and responses to agency queries.
  • Develop and maintain programming macros to support internal data review and monitoring.

Experience and Qualifications for the Manager, Statistical Programming Role

  • Minimum of 5-7 years of industry experience in statistical programming, with extensive experience in SDTM.
  • Demonstrated experience engaging with stakeholders and managing vendor relationships.
  • Proven track record as a hands-on, individual contributor in statistical programming.
  • Advanced proficiency in SAS programming and comprehensive knowledge of CDISC SDTM and ADaM standards.
  • Solid understanding of statistical concepts related to clinical trials and their regulatory requirements.
  • Experience in all phases of drug development, from early to late-stage clinical development and submission processes.
  • Strong background in applied statistics and advanced statistical methods using SAS and R.
  • Proven experience in providing programming expertise at the project level for at least two global development projects.

    • This is an exciting opportunity to join a rapidly growing team within a household name in pharmaceuticals that is making significant strides in the field of oncology.