Senior Statistical Programmer

• Fill the Statistical Programming Lead role on projects
• Input into and negotiate statistical programming timelines and ensure adherence
• Coordinate and lead statistical programming teams to complete studies within timelines and budget
• Monitor project resourcing and budgets and identify scope changes
• Coordinate project start-up activities, global programs, tracking spreadsheets, and required documentation
• Review statistical analysis plans, mock-shells, and database set-up specifications
• Interact with sponsors and internal stakeholders regarding statistical programming issues
• Assist project teams in resolving daily work problems
• Produce and QC derived datasets, tables, figures, and data listings using efficient programming techniques
• Produce and QC dataset specifications, process-supporting documents, and submission documentation
• Ensure QC of process and technical activities in accordance with quality standards, SOPs/Guidelines, ICH-GCP, and regulatory requirements
• Maintain and expand local and international regulatory knowledge
• Provide training and mentorship to staff and project teams
• Maintain study documentation for traceability and regulatory compliance
• Participate in audits and regulatory inspections as required
• 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 knowledge of CDISC, 21 CFR Part 11, and electronic submissions

• Educated to degree level in a relevant discipline and/or equivalent work experience
• Competent in written and oral English
• Excellent analytical skills
• Proficiency in SAS
• 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 and organizational skills
• Ability to manage competing priorities and adapt to change
• Attention to detail
• Ability to successfully lead a global team
• Effective time management
• Good presentation skills
• Good business awareness and business development skills, including financial awareness
• Excellent communication skills

• No benefits, perks, or compensation extras are specified in the posting.