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R/SAS Statistical Programmer (hiring in Armenia, Hungary, Estonia, CR, Romania, Argentina, Brazil, UK, South Africa or Columbia only)

Description

R/SAS Statistical Programmer responsible for developing statistical programs, generating tables, listings, graphics and derived datasets using R and SAS to support clinical trial reporting. Ensures quality, regulatory compliance and timely delivery of programming deliverables.

Job Responsibilities

Must be located in one of the following locations with no sponsorship needed: Armenia, Hungary, Estonia, CR, Romania, Argentina, South Africa, Brazil, or Columbia.

Develop custom programming code in R and SAS to produce summary tables, data listings, graphs and datasets as defined in the statistical analysis plan and programming specifications.

Perform validation programming and collaborate with programmers, biostatisticians and project team members to resolve discrepancies and findings.

Keep project team members informed of programming progress and any issues requiring attention.

Follow SOPs, Work Instructions and relevant regulatory guidance (e.g., ICH).

Maintain organized, up-to-date project documentation, testing, verification and quality control documents and programs ensuring inspection readiness.

Manage scheduling and time constraints across multiple projects, adjusting priorities and reorganizing daily workload as needed.

Develop specifications for datasets and outputs of any complexity according to sponsor requirements, anticipating and addressing potential programming issues.

Conduct internal meetings, distribute relevant information and follow up on action items.





Work collaboratively with others and assist with projects and initiatives as necessary to meet business needs.

Ensure on-time delivery of concurrent programming deliverables, negotiate timelines and provide risk mitigation plans.

Act as lead statistical programmer, directing programming activities of other personnel and monitoring deliverable progress.

Review project documentation such as the Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs and SAS database design, providing constructive feedback.

Participate in sponsor, kickoff and bid defense meetings as the statistical programming representative.

Mentor programming personnel via training courses, presentations, review of work and feedback.

Maintain a strong working knowledge of clinical drug development, industry standards and electronic submission requirements; serve as a technical expert for complex programming questions.

Work cooperatively with biostatistics and programming staff to establish SOPs, guidelines and procedures.

Contribute technical expertise to develop programming tools and macros for standardization and efficiency.

Serve as a subject matter expert for CDISC and other regulatory requirements, providing guidance, training and compliance reviews of deliverables (e.g., SDTM, ADaM,



DEFINE.XML).

Participate in industry standards organizations and provide updates to the Biometrics Department.

Transfer deliverables as needed.

Perform other work-related duties as assigned.

Minimal travel may be required.

Qualifications

Undergraduate degree in a scientific or statistical discipline, or equivalent combination of education and programming experience.

Extensive programming experience in R or other required software, preferably in a clinical trial environment, leading multiple complex and/or general projects with teams of statistical programmers.

Experience with CDISC Standards for regulatory agency requirements, including SDTM and ADaM.

Experience in regulatory submissions preferred.

Experience mentoring others in the clinical trial process and CDISC Standards.

Excellent written and verbal communication skills.

Proficient in reading, writing, speaking and understanding English.

R programming required; SAS programming expertise optional.

Strong ADAM safety and efficacy experience with SAS and R.

1. 8 years of experience is ideal.

Additional Information

Tasks, duties, and responsibilities listed in this job description are not exhaustive. The Company may assign other tasks, duties or job responsibilities. Equivalent experience, skills, and/or education may be considered. The Company will determine what constitutes equivalent qualifications.

All employment practices comply with applicable legislation and the EU Equality Directive, the Americans with Disabilities Act, and other relevant laws.

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📌 R/SAS Statistical Programmer (hiring in Armenia, Hungary, Estonia, CR, Romania, Argentina, Braz[...] (Buenos Aires)
🏢 Syneos Health
📍 Buenos Aires