Principal Statistical Programmer leading SAS-based clinical trial programming for Alira Health. Developing CDISC datasets, analyses, documentation, and mentoring programming teams.
Responsibilities
Lead statistical programming activities on clinical projects, including complex projects
Support identification of project scope changes 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 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, customer complaints, and manage CAPAs
Supervise 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 the Project Manager or Associate Director within 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
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
Knowledge of R language is a plus
Very good knowledge of principles and techniques for clinical research
Good English communication
Good computer skills, with proficiency in Microsoft Word, Excel and PowerPoint
Quality-focused and results-oriented
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
Benefits
Hybrid work arrangement
Regular employment contract
Referral application option for referred candidates
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