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

🔥 16 hours ago

🌐 United Kingdom, South Africa – Remote

🇬🇧 United Kingdom – Remote 🇿🇦 South Africa – Remote

⏱ Part Time

🔴 Lead

🖥 Software Engineer

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Use SAS or other software to develop custom programming code for summary tables, data listings, graphs, and derived datasets • Ensure outputs meet quality standards and project requirements • Perform validation programming and resolve discrepancies with programmers, biostatisticians, and project team members • Keep project team members informed of programming progress and issues • Follow applicable SOPs, WIs, and relevant regulatory guidelines such as ICH • Maintain complete, current project documentation, testing, verification, and quality-control records • Manage schedules and priorities across multiple concurrent projects • Develop specifications for datasets and outputs of any complexity • Conduct effective internal meetings and follow action items through completion • Deliver concurrent programming deliverables on time and provide risk mitigation plans • Act as lead statistical programmer, directing other programming personnel and monitoring deliverables • Review Statistical Analysis Plans, mock shells, programming specifications, annotated CRFs, and SAS database designs • Participate in sponsor, kickoff, and bid defense meetings as statistical programming representative • Mentor programming personnel through training, work reviews, feedback, and guidance • Serve as a technical expert on clinical drug development, industry standards, electronic submissions, and complex programming questions • Establish SOPs, guidelines, policies, and procedures with biostatistics and statistical programming personnel • Develop programming tools and macros for standardization and efficiency • Provide guidance and training on CDISC Standards • Perform compliance reviews of CDISC deliverables, including SDTM and ADaM specifications and datasets and DEFINE.XML • Participate in industry standards organizations and update the Biometrics Department on standards changes • Transfer deliverables • Perform other work-related duties as assigned

🎯 Requirements

• Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment • Ability to lead multiple complex and/or global projects with teams of statistical programmers • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements • Experience in submissions to a regulatory agency preferred • Experience in mentoring others in clinical trial process and CDISC Standards • Excellent written and verbal communication skills • Ability to read, write, speak and understand English

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Opportunity to collaborate with colleagues from across the world