Statistical Programmer for Clinical Data Analysis

4 weeks ago

Toronto, Canada Connect Life Sciences Inc Full time

Job Description

The Statistical Programmer will provide hands-on data analysis support in clinical project teams. This individual will participate in the design, development, documentation, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data and analysis results for studies. Key Responsibilities:

  • Use SAS to generate and validate tables, listings, and figures (TLFs) based on SAP.
  • Perform data analysis for various needs using major statistical programming languages.
  • Provide statistical analysis support for post-approval studies.
  • Evaluate and ensure CDISC compliance of study tabulation and analysis data files.
  • Write specifications and statistical programs to generate analysis datasets and outputs.
  • Perform data analysis tasks with minimal supervision.
  • Provide programming support for data management.
  • Develop statistical toolboxes for advanced data modeling, tabulation, and visualization.
  • Participate in reviewing and validating data analysis results.

Qualifications:

  • Strong SAS programming skills in producing various types of outputs, such as TLFs and datasets, with a minimum of 3 years of experience.
  • Extensive statistical programming experience in producing deliverables on scheduled or ad-hoc basis.
  • BS degree in Statistics, Mathematics, Computer Science, or related field; MS in Statistics or Biostatistics is preferred.
  • Experience with producing outputs submitted to the FDA and other regulatory agencies.
  • Excellent organizational skills to prioritize multiple tasks and goals to ensure timely completion.
  • Attention to detail and ability to adapt to a fast-paced environment.
  • Ability to work independently and in a cross-functional team.
  • Excellent communication skills.
  • Sufficient knowledge in CDISC and SDTM/ADAM for FDA submission compliance.
  • Adequate knowledge in clinical trial research methodology, ICH, GCP, and regulations.
  • Experiences in medical device and cardiovascular disease are desirable but not required.

About Us

Connect Life Sciences Inc is a leading provider of clinical data analysis services. We are committed to delivering high-quality solutions that meet the needs of our clients.

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