Principal, Statistical Programmer

Alira Health; Toronto; On-site; CAD 110,000 - 170,000; Full time

Job summary

Alira Health is seeking a Principal Statistical Programmer to lead and support statistical programming on client clinical projects, including complex studies. You will specify, program and validate SDTM/ADaM datasets and statistical results, ensuring high quality deliverables and SOP compliance.

With 5+ years in statistical programming and strong SAS skills, you will mentor junior staff, contribute to audits and drive process improvements within a collaborative team environment in Canada.

Qualifications

• BSc/MSc or equivalent with experience in statistics, CS or mathematics.
• At least 5 years of experience in statistical programming.
• Excellent SAS programming skills.
• Knowledge of R language is a plus.
• Strong knowledge of clinical research principles.

Responsibilities

• Lead statistical programming activities on clinical projects, including complex programs.
• Program and validate CDISC SDTM and ADaM datasets and outputs.
• Prepare and review statistical analysis results, tables, listings and figures.
• Produce CDISC documentation and randomization lists.
• Ensure SOP compliance and manage project risks to delivery.
• Provide supervision and mentoring to programming team members.
• Support internal/external audits and quality assurance activities.
• Identify process improvements and lead department initiatives.

Skills

SAS programming

R language

Clinical research principles

Analytical thinking

Leadership

Education

BSc/MSc or equivalent

Statistics/Computer Science/Mathematics

BS in Computer & Information Science; Mathematics; Statistics

Job description

Job Description Summary

Job Description

ROLE

The Principal Statistical Programmer will support and lead statistical programming activities conducted on client clinical projects, including complex projects; producing high quality deliverables to agreed timelines and following relevant standard operating procedures. The principal statistical programmer will also support in the effective deployment of project resources and will support the maintenance of an efficient statistical programming department.

KEY RESPONSIBILITIES

• Lead statistical programming activities on clinical projects including complex projects
• Provide support in the identification of changes in project scope and potential risks to contractual delivery
• Act as support statistical programmer on clinical projects
• Specify, program and validate CDISC SDTM and ADaM datasets
• Specify, program and validate the statistical analysis results including analysis datasets, tables, listings and figures
• Produce and review CDISC documentation
• Create and validate randomization lists
• Ensure compliance to SOPs
• Report deviations, KPIs, customer complaints and managing CAPAs
• Provide supervision on tasks carried out by statistical programmers
• Provide guidance and mentoring to programming team members on procedures and technical standards
• Prepare and perform 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 Project Manager/Associate Director in an appropriate timeframe
• Support Quality Assurance in internal and external audits
• Support the maintenance of an effective statistical programming department
• Conduct other statistical programming related activities as required

DESIRED QUALIFICATION & EXPERIENCE

• 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
• Knowledge of R language is a plus
• Very good knowledge of principles and techniques for clinical research

TECHNICAL COMPETENCES & SOFT SKILLS

• Good English communication
• Good computer skills, with proficiency in use of Microsoft Word, Excel and PowerPoint
• Quality focused and results orientated
• Confident leader of teams
• Ability to effectively prioritize
• Trustworthy and strong team player
• Willingness to learn
• Ability to explain complex Statistical Programming concepts clearly
• Analytical thinking and problem solving skills
• Innovative thinker

Languages

English

Education

Bachelor of Science (BS): Computer and Information Science, Bachelor of Science (BS): Mathematics, Bachelor of Science (BS): Statistics

Contract Type

Regular

Salary Range

The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.