Senior Statistical Programmer, SAS Programmer
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Job Description
Senior SAS Programmer supporting Parexel’s clinical trials through statistical programming, data analysis, and regulatory reporting. Leading global teams and ensuring quality, timelines, budgets, and compliance.
Responsibilities:
- Provide technical expertise for the conduct of clinical trials
- Act as an internal subject matter expert and provide technical support and expert advice
- Support programming activities related to analysis and reporting of clinical study data
- Fill the Statistical Programming Lead role on projects when required
- Liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas
- Monitor quality, timelines, resource allocation, productivity, and budgets
- Negotiate and manage statistical programming timelines
- Coordinate and lead statistical programming teams to complete studies within timelines and budget
- Monitor project resourcing, budgets, and scope changes
- Coordinate project start-up activities and required documentation
- Review statistical analysis plans, mock-shells, and database set-up specifications
- Resolve problems encountered by project teams
- Produce and QC derived datasets, tables, figures, and data listings using efficient programming techniques
- Produce and QC dataset specifications, process documents, and submission documentation
- Perform QC in accordance with quality standards, SOPs/Guidelines, ICH-GCP, and regulatory requirements
- Provide training and mentorship
- Maintain study documentation for traceability and regulatory compliance
- Participate in audits and regulatory inspections
- Lead or participate in process and quality improvement initiatives
- Provide consultancy to internal and external sponsors
- Represent Parexel at sponsor marketing and technical meetings
- Apply regulatory requirements concerning CDISC, 21 CFR Part 11, and electronic submissions
Requirements:
- University degree
- Strong written and verbal English communication skills
- Proficiency in SAS
- Excellent analytical skills
- Ability to successfully lead a global team
- Extensive knowledge and understanding of the programming and reporting process
- Knowledge of SOPs/Guidelines, ICH-GCP, and applicable local and international regulations such as 21 CFR Part 11
- Ability to learn new systems and function in an evolving technical environment
- Strong project management skills
- Strong organizational skills, ability to manage competing priorities, and flexibility to change
- Attention to detail
- Effective time management to meet daily metrics or team objectives
- Business/operational skills including customer focus, commitment to quality management, and problem solving
- Good presentation skills
- Good business awareness/business development skills, including financial awareness
Benefits:
- Professional growth and development opportunities
- Work-life balance
- Flexible working hours
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