Senior Statistical Programmer
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Job Description
Senior Statistical Programmer leading SAS clinical-trial programming for Syneos Health’s integrated life-sciences services. Developing SDTM, ADaM, and TLF outputs while mentoring programmers.
Responsibilities:
- 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 materials
- Manage schedules and priorities across multiple projects
- Develop specifications for datasets and outputs according to statistical and sponsor requirements
- Anticipate and address programming issues and define variables for peer review and sponsor/requestor approval
- Prepare for and conduct internal meetings, distribute information and minutes, and follow action items to completion
- Negotiate time estimates and complete study programming activities within allotted timelines
- Act as lead statistical programmer and direct other programming personnel
- Monitor programming deliverables and review study documentation including SAPs, mock shells, programming specifications, annotated CRFs, and SAS database designs
- Participate in sponsor, kickoff, and bid defense meetings as the statistical programming representative
- Mentor programming personnel through training, work reviews, feedback, and guidance
- Transfer deliverables and perform other assigned work-related duties
Requirements:
- 5-8 years of experience
- End-to-end programming experience
- Strong hands-on expertise in SDTM, ADaM, and TLF development
- Exposure to efficacy endpoints and analyses
- Basic understanding or training in R Programming
- Experience in Oncology or Non-Oncology studies
- Extensive programming experience in SAS or other required software, preferably in a clinical trial environment
- Excellent written and verbal communication skills
- Ability to read, write, speak and understand English
- Graduate degree, preferably in a scientific or statistical discipline; an equivalent combination of education and demonstrated programming experience may be considered
- Immediate joiners are preferred
- Minimal travel may be required
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations when appropriate
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