Junior Statistical SAS Programmer

OPIS; Livorno; In loco; EUR 30.000 - 45.000; Tempo pieno

Descrizione del lavoro

A leading international CRO is seeking a Junior Statistical SAS Programmer to develop SAS programs for clinical studies. The role involves collaboration with Biostatistics and Data Management teams, ensuring compliance with ICH E3 guidelines. Candidates should have a scientific degree and experience in SAS programming, with opportunities for professional development offered.

Servizi

Competitive salary

Bonuses

Benefits

Professional development opportunities

Competenze

• At least 1 year of experience in CRO, biotech, pharma, or research institutes preferred.
• Fluency in English.
• Strong planning and team skills.

Mansioni

• Develop SAS programs for clinical trials and publications.
• Use CDISC guidelines to generate datasets.
• Validate ADaM datasets using Pinnacle 21.

Conoscenze

SAS programming

CDISC standards

Statistical understanding

Communication skills

Organizational skills

Formazione

Scientific degree

Descrizione del lavoro

The Junior Statistical SAS Programmer, under the supervision of the Direct Manager, is primarily responsible for developing SAS programs to generate datasets, tables, figures, and listings for clinical studies in accordance with ICH E3 guidelines. The role involves collaboration with Biostatistics and Data Management teams on clinical trials or projects.

Key Responsibilities:

1. Develop SAS programs for generating datasets, tables, figures, and listings for clinical trials, publications, and Health Authorities requests.
2. Use CDISC guidelines to generate SDTM and ADaM datasets.
3. Write Programming Specifications for analysis datasets.
4. Validate ADaM datasets using Pinnacle 21.
5. Prepare, maintain, and archive CDISC documentation for ADaM, including Define.xml and ADRG.
6. Contribute to developing standard SAS macros and validation documents.
7. Liaise with Data Management to develop SAS programs/macros/utilities for data discrepancy detection.
8. Develop SAS programs for importing and reconciling external clinical data.
9. Develop and validate SAS programs for identifying Non-Protocol Deviations.
10. Maintain and archive SAS programming documentation.
11. Establish and maintain SOPs, templates, and standards related to SAS programming.
12. Stay informed on new SAS developments relevant to clinical data management.
13. Ensure KPI and metrics for studies are met.
14. Complete required trainings timely.
15. Accurately update the TRACK system daily.
16. Perform additional tasks as assigned.

Qualifications:

• Scientific degree.
• At least 1 year of experience in CRO, biotech, pharma, or research institutes preferred.
• Knowledge of HA requirements for pharmaceutical research and SAS programming.
• Understanding of statistics and clinical trial applications.
• Proficiency in SAS and CDISC standards (SDTM, ADaM).
• Fluency in English.
• Strong planning, organizational, communication, and team skills.

What We Offer:

A competitive salary, bonuses, benefits, and opportunities for professional development within an expanding international company.

About Us:

OPIS is a 25-year experienced international CRO offering comprehensive clinical research services worldwide, including drug trials, medical devices studies, and more, utilizing state-of-the-art technology and innovative approaches.