BSc/MSc in Statistics, Computer Science, or Mathematics
5+ years of experience in statistical programming
Proficient in SAS programming
Knowledge of R language is advantageous
Strong understanding of clinical research principles and techniques
Responsibilities
Lead statistical programming for complex clinical projects
Identify project scope changes and potential risks
Support statistical programming on clinical projects
Program and validate CDISC SDTM and ADaM datasets
Produce and review statistical analysis results and documentation
Create and validate randomization lists
Mentor and supervise junior programming team members
Benefits
Opportunities for professional development and training
Supportive team environment
Engagement in innovative projects
Involvement in internal initiatives for process improvement
Exposure to diverse clinical projects
Full Job Description
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Job Description SummaryJob DescriptionROLE
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 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, programand validate CDISC SDTM and ADaM datasets
Specify, programand validate the 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 develop new 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 Director in 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
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 teamplayer
Willingness to learn
Ability to explain complex Statistical Programming concepts clearly
Analytical thinking and problem solvingskills
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 candidate27s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.
About Alira Health
Alira Health is a global advisory firm providing strategy, execution and innovation services for healthcare and life sciences companies. With offices in Paris, Barcelona, Munich, Milan, New York, Boston, San Francisco and Los Angeles, Alira Health provides a range of services including strategic consulting, regulatory affairs, clinical and medical affairs, quality and safety, and transaction advisory. The company has worked with over 500 clients, including pharmaceutical, biotech, medical device and digital health companies.
