Senior Statistical Programmer – R Programming

This is a fully remote position, open to applicants in United Kingdom, +3 more countries.

📋 Description

• Deliver technical expertise for the execution of clinical trials and assist in programming activities related to the analysis and reporting of clinical study data.

• Act as an internal subject matter expert, providing technical support and expert guidance.

• Assume the role of Statistical Programming Lead on projects when necessary.

• Collaborate with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas.

• Oversee quality, timelines, resource allocation, productivity, and budgets.

• Negotiate and uphold statistical programming timelines.

• Organize and manage statistical programming teams to ensure studies are completed within timelines and budgets.

• Monitor project resources and budgets, identifying any changes in scope.

• Coordinate project initiation activities and develop global programs, tracking spreadsheets, and documentation.

• Review statistical analysis plans, mock-shells, and database setup specifications.

• Create and perform quality control on derived datasets, tables, figures, and data listings using efficient programming techniques.

• Develop and ensure quality control on dataset specifications, process-supporting documents, and submission documentation.

• Ensure compliance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and international regulatory requirements through quality control.

• Provide training, mentorship, and consultancy to staff, project teams, and sponsors.

• Maintain study documentation to ensure traceability and regulatory compliance.

• Participate in audits, regulatory inspections, and process/quality improvement initiatives.

• Represent Parexel at sponsor marketing and technical meetings.

• Understand and apply standards such as CDISC, 21 CFR Part 11, and electronic submissions.

⛳️ Requirements

• A university degree is required.

• Strong written and verbal communication skills in English.

• Proficiency in R programming.

• Excellent analytical capabilities.

• Proven ability to successfully lead a global team.

• Extensive knowledge and comprehension of the programming and reporting processes.

• Familiarity with SOPs/Guidelines, ICH-GCP, and relevant local and international regulations, including 21 CFR Part 11.

• Capability to learn new systems and thrive in a dynamic technical environment.

• Strong project management abilities.

• Exceptional organizational skills, with the capacity to manage competing priorities and adapt to change.

• Attention to detail is crucial.

• Effective time management skills to achieve daily metrics or team goals.

• Business and operational skills, including customer focus, commitment to quality management, and problem-solving abilities.

• Good presentation skills.

• Awareness of business development and financial awareness is advantageous.

🏝️ Benefits

• Opportunities for professional growth and development.

• Emphasis on work-life balance.

• Flexible working hours.

• A collaborative and inclusive work environment.