Principal Statistical Programmer, Sponsor Dedicated – Part Time or Full Time

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Utilize SAS or alternative software to create customized programming code for summary tables, data listings, graphs, and derived datasets.

• Ensure that outputs comply with quality standards and fulfill project requirements.

• Conduct validation programming and address discrepancies in collaboration with programmers, biostatisticians, and project team members.

• Keep project team members updated on programming progress and any issues encountered.

• Adhere to relevant SOPs, WIs, and applicable regulatory guidelines such as ICH.

• Maintain thorough, up-to-date project documentation, testing, verification, and quality-control records.

• Oversee schedules and priorities across multiple simultaneous projects.

• Create specifications for datasets and outputs of varying complexity.

• Facilitate effective internal meetings and ensure action items are completed.

• Deliver concurrent programming outputs punctually and provide risk mitigation strategies.

• Act as the lead statistical programmer, guiding other programming staff and overseeing deliverables.

• Review Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database designs.

• Represent statistical programming in sponsor, kickoff, and bid defense meetings.

• Mentor programming staff through training, work evaluations, feedback, and guidance.

• Serve as a technical authority on clinical drug development, industry standards, electronic submissions, and complex programming inquiries.

• Establish SOPs, guidelines, policies, and procedures in collaboration with biostatistics and statistical programming teams.

• Create programming tools and macros to enhance standardization and efficiency.

• Provide guidance and training on CDISC Standards.

• Conduct compliance reviews of CDISC deliverables, including SDTM and ADaM specifications, datasets, and DEFINE.XML.

• Participate in industry standards organizations and keep the Biometrics Department informed about changes in standards.

• Transfer deliverables as required.

• Execute other job-related duties as assigned.

⛳️ Requirements

• Bachelor's degree, ideally in a scientific or statistical field; alternatively, an equivalent combination of education and proven programming experience.

• Extensive programming experience in SAS or other necessary software, preferably within a clinical trial context.

• Capability to manage multiple complex and/or global projects with teams of statistical programmers.

• Familiarity with and experience in applying CDISC Standards to meet regulatory agency requirements.

• Experience in submissions to regulatory agencies is preferred.

• Background in mentoring others regarding the clinical trial process and CDISC Standards.

• Exceptional written and verbal communication abilities.

• Proficiency in reading, writing, speaking, and understanding English.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical skills and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Chance to collaborate with colleagues globally.