BSc/MSc in Statistics, Computer Science, or Mathematics
5+ years of experience in statistical programming
Proficient in SAS programming
Familiarity with 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
Act as a support statistical programmer on projects
Program and validate CDISC SDTM and ADaM datasets
Produce and review CDISC documentation
Create and validate randomization lists
Mentor and guide programming team members
Benefits
Opportunity for professional development and training
Supportive team environment
Engagement in innovative projects
Involvement in quality assurance processes
Potential for leadership roles in future projects
Full Job Description
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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
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.
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.
