R/SAS Statistical Programmer (hiring in Armenia, Hungary, Estonia, CR, Romania, Argentina, Brazil, or Columbia only)
Syneos Health is a leading, fully integrated life sciences services organization. We seek an R/SAS Statistical Programmer based in the listed locations to support clinical trial data analysis.
Responsibilities
* Must be located in Armenia, Hungary, Estonia, CR, Romania, Argentina, Brazil, or Columbia with no sponsorship needed.
* R and SAS programming experience required.
* CDISC SDTM/ADAM programming experience required.
* Use R and SAS to develop custom programming code to generate summary tables, data listings, graphs, and derived datasets as specified in the statistical analysis plan and programming specifications.
* Perform validation programming and resolve discrepancies with other programmers, biostatisticians, and project team members.
* Keep project team members informed of programming progress and issues requiring their attention.
* Follow applicable SOPs, written instructions, and regulatory guidelines (e.g., ICH).
* Maintain well‑organized, complete, and up‑to‑date project documentation, testing, and verification/quality control documents and programs to ensure inspection readiness.
* Manage scheduling and time constraints across multiple projects, setting goals based on management priorities and adapting to timelines or priority changes.
* Develop specifications for datasets and outputs of any complexity according to statistical or sponsor requirements.
* Conduct effective internal meetings, distribute relevant information in advance, ensure minutes are promptly and accurately distributed, and follow action items through to completion.
* Display willingness to work with others and assist with projects and initiatives as needed.
* Be accountable for on‑time delivery across concurrent programming deliverables, negotiate programming timelines, and provide risk mitigation plans.
* Act as the lead statistical programmer, directing the programming activities of other programming personnel and monitoring progress.
* Review project documentation such as the Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design, providing feedback that reduces inefficiencies.
* Participate in sponsor meetings, kickoff meetings, and bid defense meetings as the statistical programming representative, as required by the sponsor.
* Contribute to mentoring of programming personnel through training courses, presentations, and guidance of new associates.
* Maintain a good working knowledge of clinical drug development, industry standards, and electronic submission requirements, serving as a technical expert resource.
* Work cooperatively with other biostatistics and statistical programming personnel to establish SOPs, guidelines, policies, and procedures.
* Contribute technical expertise to develop programming tools and macros for standardization and efficiency.
* Serve as a technical subject‑matter expert for CDISC and other industry standards, providing guidance and training to the broader team.
* Perform compliance reviews of project deliverables for CDISC compliance, including SDTM, ADaM, and regulatory required documents (e.g., DEFINE.XML).
* Participate in industry standards organizations and provide updates on upcoming changes to the Biometrics Department.
* Transfer deliverables as required and perform other work‑related duties as assigned.
* Minimal travel may be required.
Qualifications
* Undergraduate degree, preferably in a scientific or statistical discipline, or equivalent combination of education and demonstrated programming experience.
* Extensive programming experience in R or other required software, preferably in a clinical trial environment with the ability to lead multiple complex and/or global projects.
* Knowledge and experience in the use of CDISC Standards for regulatory agency requirements; experience in regulatory submissions preferred.
* 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.
* R programming required.
Additional Information
We comply with all applicable equal‑employment‑opportunity laws, including the EU Equality Directive and the Americans with Disabilities Act, and provide reasonable accommodations where appropriate. The Company retains sole discretion to interpret and apply qualifications and determine equivalency of experience.
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