Statistical Programmer
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Job Description
Lead statistical programming for Syneos Health’s clinical drug development services. Developing SAS outputs, validating CDISC deliverables, and guiding programming teams.
Responsibilities:
- Develop custom programming code using SAS or other software to generate 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 teams informed of programming progress and issues
- Follow applicable SOPs, work instructions, and regulatory guidelines such as ICH
- Maintain complete, current project documentation, testing, and quality-control materials
- Manage schedules and priorities across multiple concurrent projects
- Develop specifications for datasets and outputs according to statistical or sponsor requirements
- Lead effective internal meetings and track action items
- Deliver concurrent programming deliverables on time and provide risk mitigation plans
- Act as lead statistical programmer and direct other programming personnel
- Review statistical analysis plans, mock shells, programming specifications, annotated CRFs, and SAS database designs
- Participate in sponsor, kickoff, and bid defense meetings
- Mentor programming personnel through training, work review, and feedback
- Serve as a technical expert on clinical drug development, industry standards, and electronic submissions
- Establish SOPs, guidelines, policies, and procedures with biostatistics and statistical programming teams
- Develop programming tools and macros for standardization and efficiency
- Provide guidance and training on CDISC Standards
- Perform compliance reviews of CDISC deliverables, including SDTM, ADaM, and DEFINE.XML
- Participate in industry standards organizations and communicate upcoming standards changes
- Transfer deliverables
- Perform other assigned work-related duties
Requirements:
- Undergraduate degree, preferably in a scientific or statistical discipline; an equivalent combination of education and demonstrated programming experience may substitute for the degree
- 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 using CDISC Standards for regulatory agency requirements
- Experience in submissions to a regulatory agency preferred
- Experience mentoring others in clinical trial processes 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
- Minimal travel may be required
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