Principal, Statistical Programmer

Alira Health•Boston, MA

About The Position

The Principal Statistical Programmer will support and lead statistical programming activities for client clinical projects, including complex projects. The role is responsible for producing high-quality deliverables on agreed timelines and in accordance with relevant standard operating procedures. It also supports effective deployment of project resources and maintenance of an efficient statistical programming department.

Requirements

  • BSc/MSc or equivalent with experience; preferably in Statistics, Computer Science, or Mathematics.
  • At least 5 years of experience in statistical programming.
  • Excellent SAS programming skills.
  • Very good knowledge of principles and techniques for clinical research.
  • Good English communication skills.
  • Good computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint.
  • Quality-focused and results-oriented.
  • Confident leader of teams.
  • Ability to effectively prioritize.
  • Trustworthy and a strong team player.
  • Willingness to learn.
  • Ability to explain complex statistical programming concepts clearly.
  • Analytical thinking and problem-solving skills.
  • Innovative thinker.

Nice To Haves

  • Knowledge of the R language.

Responsibilities

  • Lead statistical programming activities on clinical projects, including complex projects.
  • Support identification of changes in project scope and potential risks to contractual delivery.
  • Act as a support statistical programmer on clinical projects.
  • Specify, program, and validate CDISC SDTM and ADaM datasets.
  • Specify, program, and validate statistical analysis results, including analysis datasets, tables, listings, and figures.
  • Produce and review CDISC documentation.
  • Create and validate randomization lists.
  • Ensure compliance with SOPs.
  • Report deviations, KPIs, and customer complaints, and manage CAPAs.
  • Supervise tasks carried out by statistical programmers.
  • Guide and mentor programming team members on procedures and technical standards.
  • Prepare and deliver internal or external training on statistical programming techniques.
  • Identify, implement, and develop new techniques, solutions, tools, and products.
  • Identify areas for efficiency or process improvement.
  • Lead internal initiatives to improve department processes.
  • Communicate effectively with internal and external project teams.
  • Report issues to the Project Manager or Associate Director in an appropriate timeframe.
  • Support Quality Assurance in internal and external audits.
  • Support maintenance of an effective statistical programming department.
  • Conduct other statistical programming-related activities as required.
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