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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 RESPONSABILITIES
- 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
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