Senior Statistical Programmer, SAS Programmer

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

• Serve as an internal subject matter expert, offering technical support and expert advice

• Assist in programming activities related to the analysis and reporting of clinical study data

• Assume the role of Statistical Programming Lead on projects as needed

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

• Oversee quality, timelines, resource allocation, productivity, and budget management

• Negotiate and manage timelines for statistical programming

• Organize and lead statistical programming teams to ensure studies are completed within set timelines and budget

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

• Coordinate project start-up activities and the necessary documentation

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

• Address issues faced by project teams

• Generate and perform quality control on derived datasets, tables, figures, and data listings using efficient programming methods

• Create and validate dataset specifications, process documents, and submission documentation

• Execute quality control in line with quality standards, SOPs/Guidelines, ICH-GCP, and regulatory requirements

• Offer training and mentorship

• Maintain study documentation to ensure traceability and compliance with regulations

• Engage in audits and regulatory inspections

• Lead or take part in initiatives aimed at process and quality improvement

• Provide consultancy services to both internal and external sponsors

• Represent Parexel at sponsor marketing and technical meetings

• Implement regulatory requirements related to CDISC, 21 CFR Part 11, and electronic submissions

⛳️ Requirements

• Bachelor's degree

• Strong written and verbal communication skills in English

• Proficient in SAS

• Exceptional analytical capabilities

• Proven ability to effectively lead a global team

• Extensive knowledge and understanding of the programming and reporting processes

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

• Capacity to adapt to new systems and operate in a continuously evolving technical environment

• Strong project management abilities

• Excellent organizational skills, capability to juggle competing priorities, and adaptability to change

• Keen attention to detail

• Proficient time management skills to achieve daily metrics or team objectives

• Business and operational acumen, including customer focus, dedication to quality management, and problem-solving skills

• Competent presentation skills

• Strong business awareness and development skills, including financial insight

🏝️ Benefits

• Opportunities for professional growth and development

• Support for work-life balance

• Flexible working hours