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Senior Statistical Programmer - Remote

Posted 13 weeks ago
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Full Time
Worldwide

Overview

The Senior Statistical Programmer (SP) within the Ergomed Biostatistics (BS) department is responsible for the creation of SDTM/ADaM datasets and programming tables, listings and figures or other types of output, supporting and complimenting the biostatistician(s) of a project and creating and maintaining appropriate documentation.

In Short

  • Maintains responsibility for all assigned duties within a clinical study.
  • Ensures that work is performed on time.
  • Ensures all content created/reviewed is appropriate, valid, and relevant to the study and of high quality.
  • Works with other biometrics’ team members to represent the needs and input of the programming components of the study.
  • Program SDTM and ADaM datasets.
  • Create SDTM and ADaM specifications.
  • Create CDISC submission packages e.g. Define.xml and Reviewers Guide.
  • Program tables, listings, and figures in SAS from specifications.
  • Deliver training and mentorship to SP and other operational staff.
  • Act as a statistical programming expert and provide consultative support.

Requirements

  • Bachelor's Degree in Computer Science, Mathematics/Statistics, or a quantitative natural science.
  • Extensive knowledge of SAS programming and statistical programming topics relevant to clinical trials.
  • Advanced CDISC knowledge.
  • Hands-on experience using P21E.
  • Minimum of 10 years’ of experience in developing derived datasets and TFL programming.
  • Strong organization skills, including attention to detail and multitasking.
  • Excellent communication skills.
  • Knowledge of the MS Office Suite.
  • Proficiency in one or more statistical programming languages (includes SAS, R).

Benefits

  • Training and career development opportunities internally.
  • Strong emphasis on personal and professional growth.
  • Friendly, supportive working environment.
  • Opportunity to work with colleagues based all over the world.
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Ergomed

Ergomed is a specialized mid-size pharmacovigilance service provider, established in 2008, and is part of the Ergomed group. With a commitment to global organic growth, Ergomed has built a strong presence across Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. The company prides itself on maintaining long-lasting relationships with pharmaceutical and biotechnology partners, covering all therapy areas, including medical devices. Ergomed values its employees by investing in their training and development, promoting well-being and mental health, and fostering a healthy work-life balance to ensure high-quality client service.

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