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Job Description Summary
Support and lead statistical programming activities conducted on client clinical projects, including complex projects; producing high quality deliverables to agreed timelines and following relevant SOPs.Job Description
ROLE
The Principal Statistical Programmer will support andlead 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 ofproject resources and will supportthe 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, programand validate CDISC SDTM and ADaM datasets
Specify, programand validatethe statistical analysis results including analysis datasets, tables, listings and figures
Produce and review CDISC documentation
Create and validaterandomization lists
Ensure compliance to SOPs
Reportdeviations, 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 performinternal or external training on statistical programming techniques
Identify, implementand developnew techniques, solutions, tools and products
Identify areas for efficiency or process improvement
Leadinternal initiatives to improve department processes
Communicate effectively with internal and external project teams
Reportissues to Project Manager/Associate Directorin an appropriate timeframe
SupportQuality Assurance in internal and external audits
Supportthe maintenance of an effective statistical programming department
Conductother 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
Very good R programming skills
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 teamplayer
Willingness to learn
Ability to explain complex Statistical Programming concepts clearly
Analytical thinking and problem solvingskills
Innovative thinker