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Sr Statistical Programmer

  • Canada

Full-time

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Job details

Job type
Full-time
Experience
Minimum 6-8 years’ experience as a statistical programming working on clinical trials.
Posting language
English
Posted

Original job description

  • Participating in all statistical programming activities including preparing clinical data to submission using CDISC or customized standards, reviewing data conversions, data analysis datasets and outputs and taking part in creating best practices and implementation guides.
  • Might need to be responsible for project management (timelines, scope, budget, resourcing) on a project or program level.
  • Train, mentor and share knowledge with the rest of the statistical programming team.
  • Creating programming specification documents for all types of data (SDTM, ADaM, Derived data, etc.).
  • Might include Interaction with customers on a project or program level.
  • Development of SAS programs for conversion of the clinical data based on CDISC or customer instructions.
  • Development of SAS programs for analysis datasets based on SAP, shells and CDISC or customer instructions.
  • Development of SAS programs for study TFLs, based on study SAP and shells.
  • Review and verify all types of conversions and programming done based on customer requirements.
  • Development of core programs for validation, conversion, and maintenance of clinical data dataset structure.
  • Follow the appropriate Standard Operating Procedures (SOPs) for all statistical programming related activities.

Qualifications

  • A bachelor’s degree in either statistics , computer or life science discipline

Required Skills

  • Required skills:
  • Minimum 6-8 years’ experience as a statistical programming working on clinical trials.
  • Good knowledge of TFL programming.
  • Experience in programming according to CDISC standards (SDTM, ADaM), and preparing documents for submission (Reviewer’s Guide, Define.xml)
  • Attention to details.
  • Excellent communication skill
More about this job

Responsibilities

Develop and validate SAS programs for clinical data conversions, analysis datasets, and study tables, figures, and listings (TFLs), following CDISC or customer requirements. Create programming specifications and best practices, review programming outputs, and potentially manage project scope, timelines, budgets, and resources while mentoring team members and interacting with customers.

Requirements

Requires a bachelor’s degree in statistics, computer science, or a life science discipline and 6–8 years of statistical programming experience on clinical trials. Candidates should have strong TFL programming and CDISC SDTM/ADaM experience, submission documentation knowledge, attention to detail, and excellent communication skills.

Skills

  • Statistical Programming
  • SAS
  • Clinical Trials
  • CDISC
  • SDTM
  • ADaM
  • TFL Programming
  • Clinical Data Conversion
  • Analysis Datasets
  • Submission Documentation
  • Define.xml
  • Reviewer’s Guide
  • Programming Specifications
  • Data Validation
  • Project Management
  • Mentoring

Visa sponsorship

Not detected in the job text

Categories

  • Data & Analytics
  • Healthcare
  • Science & Research
  • Management & Leadership

Keywords

  • Statistical Programming
  • SAS
  • Clinical Trials
  • CDISC
  • SDTM
  • ADaM
  • TFL
  • Clinical Data
  • Data Conversion
  • Analysis Datasets
  • Submission Documentation
  • Reviewer’s Guide
  • Define.xml
  • Programming Specifications
  • Statistical Analysis Plan
  • Data Validation
  • Standard Operating Procedures
  • Project Management
  • Timelines
  • Scope Management
  • Budget Management
  • Resource Planning
  • Customer Interaction
  • Mentoring
  • Best Practices

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