R/SAS Statistical Programmer (hiring in Armenia, Hungary, …, Smalle Ee

R/SAS Statistical Programmer Hiring locations: Armenia, Hungary, Estonia, CR, Romania, Argentina, Brazil, Columbia only.

Job Responsibilities

Must be located in one of the specified locations with no sponsorship needs.

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, ensuring outputs meet quality standards and project requirements.

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

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

Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g., ICH).

Maintain well‑organized, complete, and up‑to‑date project documentation, testing, and verification/quality control documents to ensure inspection readiness.

Manage scheduling and time constraints across multiple projects, set goals based on priorities, and adapt to timeline or priority changes.

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

Conduct effective internal meetings, distribute relevant information in advance, and ensure minutes are promptly and accurately distributed.

Display willingness to work with others and assist with projects and initiatives as necessary to meet business needs.

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

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

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

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

Contribute to mentoring of programming personnel through developing training courses, presenting materials, reviewing work, and providing guidance.

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

Work cooperatively with other biostatistics and statistical programming personnel to establish SOPs, guidelines, policies, and procedures.

Contribute technical expertise to the development of programming tools and macros for standardization and efficiency.

Serve as a technical subject matter expert for CDISC and other industry/regulatory requirements, providing guidance and training on appropriate use of CDISC Standards.

Perform compliance reviews of project deliverables for CDISC deliverables, including SDTM and ADaM specifications and datasets, plus any regulatory required documents.

Actively participate in industry standards organizations and provide regular updates on upcoming changes to the Biometrics Department.

Transfer deliverables as required.

Perform other work‑related duties as assigned.

Minimal travel may be required.

Qualifications

R programming required.

Undergraduate degree, preferably in a scientific or statistical discipline; alternatively, an equivalent combination of education and demonstrated programming experience.

Extensive programming experience in R or other required software, preferably in a clinical trial environment, as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers.

Knowledge and experience in the use of CDISC Standards for regulatory agency requirements; experience in submissions to a regulatory agency preferred.

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

Excellent written and verbal communication skills.

Proficient in reading, writing, speaking, and understanding English.

Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary Roles within the Statistical Programming job family are responsible for developing programs and providing statistical programming support for statisticians or for client or business use to address needs for sourcing, organizing (creating statistical tables, listings, and graphs), and interpreting complex data sets utilizing codes and programs. This includes developing codes that create analysis datasets, tables, and figures, evaluating programming processes, and suggesting revisions geared toward increasing productivity. Impact and contribution: Individual contributors with responsibility in a professional or technical discipline or specialty may manage two or fewer employees, may direct the work of lower level professionals, and manage processes and programs. They contribute to the design, implementation, or delivery of processes, programs, and policies, achieving organizational, functional, and/or business targets with measurable impact on departmental results.

#J-18808-Ljbffr