[Hiring] Principal Statistical Programmer @Syneos Health Careers

Role Description

The Principal Stat Programmer (ADaM & TLF) is responsible for developing custom programming code to generate summary tables, data listings, graphs, and derived datasets as specified in the statistical analysis plan and programming specifications. Key responsibilities include:

• Using SAS or other software to ensure outputs meet quality standards and project requirements.
• Performing validation programming and collaborating with other programmers and biostatisticians to resolve discrepancies.
• Keeping project team members informed of programming progress and issues.
• Following applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).
• Maintaining well-organized, complete, and up-to-date project documentation and quality control documents.
• Managing scheduling and time constraints across multiple projects.
• Developing specifications for datasets and outputs according to statistical or sponsor requirements.
• Conducting effective internal meetings and ensuring action items are followed through.
• Being accountable for on-time delivery across concurrent programming deliverables.
• Acting as the lead statistical programmer and directing the programming activities of other personnel.
• Reviewing project documentation and providing feedback to reduce inefficiencies.
• Participating in sponsor meetings as the statistical programming representative.
• Contributing to the mentoring of programming personnel.
• Maintaining a good working knowledge of clinical drug development and industry standards.
• Contributing technical expertise to the development of programming tools and macros.
• Providing guidance and training on CDISC Standards.
• Performing compliance reviews of project deliverables for CDISC specifications.
• Actively participating in industry standards organizations.
• Transferring deliverables and performing other work-related duties as assigned.
• Minimal travel may be required.

Qualifications

• Undergraduate degree, preferably in a scientific or statistical discipline; equivalent combination of education and demonstrated programming experience may be considered.
• 8+ years programming experience in Clinical SAS, leading multiple complex and/or global projects.
• Strong experience in ADaM & TLF.
• Experience in submissions to a regulatory agency preferred.
• Good to have experience of pooling study.
• Experience in mentoring others in the clinical trial process and CDISC Standards.
• Excellent written and verbal communication skills.
• Ability to read, write, speak, and understand English.

Benefits

• Passionate about developing our people through career development and progression.
• Supportive and engaged line management.
• Technical and therapeutic area training.
• Peer recognition and total rewards program.
• Commitment to building an inclusive culture.
• Opportunity to shape solutions that impact lives.

Company Description

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress.

• Worked with 94% of all Novel FDA Approved Drugs over the past 5 years.
• Collaborated on 95% of EMA Authorized Products.
• Conducted over 200 Studies across 73,000 Sites and 675,000+ Trial patients.